Spiration Career Opportunities
Describe your years of experience in complex, regulated manufacturing environment
Do you have an established network of contacts in respiratory or pulmonary medical device industry (preferred but not required)?
OPTIONAL - Briefly describe a situation from a recent position that demonstrates your ability to communicate effectively with contacts throughout the organization in order to get the information you need in a timely manner.
Please note that this position is no longer available.
If you would like to be considered for similar opportunities now or in the future, feel free to apply and/or set up a notifier for yourself.
Director, International Regulatory Affairs
WA - Redmond
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Opportunity Snapshot

This newly created role offers you the opportunity to manage worldwide regulatory product approvals that will have a significant impact on the respiratory industry and our organization as a whole. As Director of International Regulatory Affairs, you will manage the international regulatory activities in an effort to obtain clinical study and product approvals. This is your opportunity to utilize your medical device and international regulatory knowledge to bring our device therapy to patients and physicians around the world.

The Role

As Director of International Regulatory Affairs, your mission will be to obtain regulatory approval to market our products in various countries around the world. To complete this task, you'll work with regulatory personnel of Olympus affiliates and representatives of international regulatory agencies to develop and implement regulatory strategies for the earliest possible international clinical study and product approvals.Quick question for you - click here

Since joining the Olympus family in 2010, we now have the ability to explore opportunities to market our product in foreign jurisdictions--which is where you would come in. Reporting to the Director of Regulatory Affairs, but working independently to achieve the goals of the international regulatory strategy, you will also work closely with the COO and with the engineering and clinical teams to develop strategies and navigate the registration process.

More specifically, you will:
  • Work with Olympus affiliates to develop and implement international, country-specific regulatory strategies and approval process plans.
  • Provide technical guidance and support for international regulatory submission preparation and interaction with corresponding regulatory bodies.
  • Manage preparation and submission of international regulatory applications as appropriate, as well as internal, international regulatory file documentation.
  • Assist Olympus affiliates with developing and maintaining positive relationships with international regulatory reviewers through oral and written communications regarding pre-submission strategy/regulatory/pathway development, testing requirements, clarification, and follow up of international submissions under review.
  • Provide effective communication to Spiration ORA management regarding international regulatory requirements, the status of regional submission strategies, regulatory body inquiries, and international product approvals.
  • Provide technical leadership and guidance through the interpretation of new and emerging international regulatory trends pertinent to Spiration ORA business needs, and recommend strategies and activities to optimize international regulatory performance in light of those trends.
  • Evaluate new and revised international regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
  • Participate in and make recommendations for Spiration ORA international regulatory strategy for existing and new products, working closely with the Director, Regulatory Affairs, the Director, Quality Systems, International Marketing personnel, and senior management.
  • Manage outside consultants and contractors that directly relate to job responsibilities (communication, scheduling, project status, and budgets/invoices).
  • Support the Director, Regulatory Affairs in the review of controlled document changes for international regulatory impact and risk.
  • Assist in the planning and execution of international clinical studies to generate data for regulatory submissions.
  • Assist the Director, Regulatory Affairs and Olympus Affiliates in the review of international device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
  • Assist the Director, Quality Systems with compliance activities related to QSR Regulations and ISO quality system standards.
  • Assist the Director, Regulatory Affairs, with the responsibility to ensure proper management of the Regulatory Affairs Department's financial budget, forecast changes, and invoicing activity.
In addition to these regulatory responsibilities, you should also have some aptitude for technical knowledge and an interest in knowing how our products work. You'll be working closely with different departments and all levels of management within our organization, so taking the time to understand the the technical, engineering, and clinical aspects of our product will be a valuable asset in this role.

Experience with international product registration with a base of products that have not been approved in the U.S. will also be very helpful. You'll be looking at worldwide registration regulations in a multitude of countries and we're looking for someone who can tap-in to their network of industry contacts and our affiliates to quickly and efficiently obtain product approvals.
 

The Requirements

To be a good fit for this opportunity you will have:
  • At least 7 to 10 years of directly-related international regulatory medical device experience in a management role. Quick question for you - click here
  • A bachelor's degree in science or engineering preferred; advanced degree desirable.
  • Strong technical knowledge of medical device products and competitive international market.
  • Extensive experience and understanding of U.S. Export Regulations, particularly the export of U.S. manufactured products that are not approved for sale in the U.S.
  • Direct experience and a thorough understanding of Notified Bodies and international regulatory compliance.
  • Extensive knowledge of and experience with international regulatory requirements for implantable medical device product development and registration.
  • Experience working with CROs and/or contractors and the conduct of clinical trials in countries outside the U.S.
  • The following interpersonal skills and qualities:
    • Excellent negotiation and communication skills and the ability to work independently and function well in a team-orientated environment.
    • Highly-developed written and verbal communications, management, and leadership skills.
    • The ability to develop strong working relationships with Olympus affiliates, international regulatory agency personnel, and Spiration ORA team members.
    • The ability to help formulate global regulatory strategies based on understanding of the product and hands-on experience in regulatory procedures to achieve competitive and speedy product approvals.
Preferred but not required:
  • Prior director level management experience.
  • RAC, CQA, and CQM Certifications.

Why Spiration

The "best of both worlds": Yes, we are growing -- we have sixty-some full-time employees -- but we're still small enough that each of us contributes on multiple levels. You'll enjoy the close-knit environment of a smaller company coupled with the infrastructure and support of a larger organization.

High potential product: The IBV Valve System has received CE Mark approval and is being marketed in Europe. In the U.S. the IBV Valve System received Humanitarian Device Exemption (HDE) market approval for the treatment of prolonged air leaks following specific lung surgeries. The device is also under investigation in the U.S. as a new treatment for patients with severe emphysema.

Autonomy and support: While we'll look to you to achieve your goals with minimal supervision, the Director of Regulatory Affairs and other senior management will serve as mentors and can provide you with the historical knowledge and industry insight to help you achieve your goals. You'll have support when you need it and independence when you don't.

Great work environment: At Spiration, we pride ourselves on our scientific expertise and cutting-edge technologies. We have created a culture that is open, collaborative, and fun with leadership committed to quality and regulatory compliance. If you're not already familiar with Redmond, WA, it is a hub of medical device and biotech industries, and a beautiful suburb of Seattle.

A proud subsidiary of the Olympus Corporation: In 2010, we joined Olympus Medical Systems Corp (OMSC), a world leader in the respiratory market with solutions for endoscopic observation, diagnosis and treatment. In this partnership, Spiration Inc.-Olympus Respiratory America will continue to expand its business to address acute and chronic conditions of the lung through the development of novel therapies

Excellent compensation: In addition to a competitive salary, we offer a rich benefits package that includes excellent health care, vacation and other paid leave.

Keys to Success

Communication is key for success in this role. You'll not only be interacting with internal groups across the organization but also with affiliates throughout the world, where in many cases, English is not their primary language. Because of the diverse interactions you will encounter on a daily basis, your interpersonal communication skills will need to be topnotch. Quick question for you - click here

We are a group who moves quickly, and as Director, International Regulatory Affairs, you'll need to be able to seamlessly transition from high-level strategy planning to detailed registration applications quickly and effortlessly. We're looking for a self-starter with a knack for independent thinking and drive for results.

About Spiration

Spiration is committed to improving the quality of life for patients with acute and chronic conditions of the lung through the development of novel therapies. Our company was founded in 1999 in Redmond, WA, and in 2010, became part of Olympus Medical Systems Corp. Spiration Inc.-Olympus Respiratory America will continue its mission to be a pioneer in the field of lung therapy.

Opportunity Snapshot

This newly created role offers you the opportunity to manage worldwide regulatory product approvals that will have a significant impact on the respiratory industry and our organization as a whole. As Director of International Regulatory Affairs, you will manage the international regulatory activities in an effort to obtain clinical study and product approvals. This is your opportunity to utilize your medical device and international regulatory knowledge to bring our device therapy to patients and physicians around the world.

The Role

As Director of International Regulatory Affairs, your mission will be to obtain regulatory approval to market our products in various countries around the world. To complete this task, you'll work with regulatory personnel of Olympus affiliates and representatives of international regulatory agencies to develop and implement regulatory strategies for the earliest possible international clinical study and product approvals.Quick question for you - click here

Since joining the Olympus family in 2010, we now have the ability to explore opportunities to market our product in foreign jurisdictions--which is where you would come in. Reporting to the Director of Regulatory Affairs, but working independently to achieve the goals of the international regulatory strategy, you will also work closely with the COO and with the engineering and clinical teams to develop strategies and navigate the registration process.

More specifically, you will:
  • Work with Olympus affiliates to develop and implement international, country-specific regulatory strategies and approval process plans.
  • Provide technical guidance and support for international regulatory submission preparation and interaction with corresponding regulatory bodies.
  • Manage preparation and submission of international regulatory applications as appropriate, as well as internal, international regulatory file documentation.
  • Assist Olympus affiliates with developing and maintaining positive relationships with international regulatory reviewers through oral and written communications regarding pre-submission strategy/regulatory/pathway development, testing requirements, clarification, and follow up of international submissions under review.
  • Provide effective communication to Spiration ORA management regarding international regulatory requirements, the status of regional submission strategies, regulatory body inquiries, and international product approvals.
  • Provide technical leadership and guidance through the interpretation of new and emerging international regulatory trends pertinent to Spiration ORA business needs, and recommend strategies and activities to optimize international regulatory performance in light of those trends.
  • Evaluate new and revised international regulations/guidance for impact on product development plans in order to propose and implement appropriate changes.
  • Participate in and make recommendations for Spiration ORA international regulatory strategy for existing and new products, working closely with the Director, Regulatory Affairs, the Director, Quality Systems, International Marketing personnel, and senior management.
  • Manage outside consultants and contractors that directly relate to job responsibilities (communication, scheduling, project status, and budgets/invoices).
  • Support the Director, Regulatory Affairs in the review of controlled document changes for international regulatory impact and risk.
  • Assist in the planning and execution of international clinical studies to generate data for regulatory submissions.
  • Assist the Director, Regulatory Affairs and Olympus Affiliates in the review of international device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
  • Assist the Director, Quality Systems with compliance activities related to QSR Regulations and ISO quality system standards.
  • Assist the Director, Regulatory Affairs, with the responsibility to ensure proper management of the Regulatory Affairs Department's financial budget, forecast changes, and invoicing activity.
In addition to these regulatory responsibilities, you should also have some aptitude for technical knowledge and an interest in knowing how our products work. You'll be working closely with different departments and all levels of management within our organization, so taking the time to understand the the technical, engineering, and clinical aspects of our product will be a valuable asset in this role.

Experience with international product registration with a base of products that have not been approved in the U.S. will also be very helpful. You'll be looking at worldwide registration regulations in a multitude of countries and we're looking for someone who can tap-in to their network of industry contacts and our affiliates to quickly and efficiently obtain product approvals.
 

The Requirements

To be a good fit for this opportunity you will have:
  • At least 7 to 10 years of directly-related international regulatory medical device experience in a management role. Quick question for you - click here
  • A bachelor's degree in science or engineering preferred; advanced degree desirable.
  • Strong technical knowledge of medical device products and competitive international market.
  • Extensive experience and understanding of U.S. Export Regulations, particularly the export of U.S. manufactured products that are not approved for sale in the U.S.
  • Direct experience and a thorough understanding of Notified Bodies and international regulatory compliance.
  • Extensive knowledge of and experience with international regulatory requirements for implantable medical device product development and registration.
  • Experience working with CROs and/or contractors and the conduct of clinical trials in countries outside the U.S.
  • The following interpersonal skills and qualities:
    • Excellent negotiation and communication skills and the ability to work independently and function well in a team-orientated environment.
    • Highly-developed written and verbal communications, management, and leadership skills.
    • The ability to develop strong working relationships with Olympus affiliates, international regulatory agency personnel, and Spiration ORA team members.
    • The ability to help formulate global regulatory strategies based on understanding of the product and hands-on experience in regulatory procedures to achieve competitive and speedy product approvals.
Preferred but not required:
  • Prior director level management experience.
  • RAC, CQA, and CQM Certifications.

Why Spiration

The "best of both worlds": Yes, we are growing -- we have sixty-some full-time employees -- but we're still small enough that each of us contributes on multiple levels. You'll enjoy the close-knit environment of a smaller company coupled with the infrastructure and support of a larger organization.

High potential product: The IBV Valve System has received CE Mark approval and is being marketed in Europe. In the U.S. the IBV Valve System received Humanitarian Device Exemption (HDE) market approval for the treatment of prolonged air leaks following specific lung surgeries. The device is also under investigation in the U.S. as a new treatment for patients with severe emphysema.

Autonomy and support: While we'll look to you to achieve your goals with minimal supervision, the Director of Regulatory Affairs and other senior management will serve as mentors and can provide you with the historical knowledge and industry insight to help you achieve your goals. You'll have support when you need it and independence when you don't.

Great work environment: At Spiration, we pride ourselves on our scientific expertise and cutting-edge technologies. We have created a culture that is open, collaborative, and fun with leadership committed to quality and regulatory compliance. If you're not already familiar with Redmond, WA, it is a hub of medical device and biotech industries, and a beautiful suburb of Seattle.

A proud subsidiary of the Olympus Corporation: In 2010, we joined Olympus Medical Systems Corp (OMSC), a world leader in the respiratory market with solutions for endoscopic observation, diagnosis and treatment. In this partnership, Spiration Inc.-Olympus Respiratory America will continue to expand its business to address acute and chronic conditions of the lung through the development of novel therapies

Excellent compensation: In addition to a competitive salary, we offer a rich benefits package that includes excellent health care, vacation and other paid leave.

Keys to Success

Communication is key for success in this role. You'll not only be interacting with internal groups across the organization but also with affiliates throughout the world, where in many cases, English is not their primary language. Because of the diverse interactions you will encounter on a daily basis, your interpersonal communication skills will need to be topnotch. Quick question for you - click here

We are a group who moves quickly, and as Director, International Regulatory Affairs, you'll need to be able to seamlessly transition from high-level strategy planning to detailed registration applications quickly and effortlessly. We're looking for a self-starter with a knack for independent thinking and drive for results.

About Spiration

Spiration is committed to improving the quality of life for patients with acute and chronic conditions of the lung through the development of novel therapies. Our company was founded in 1999 in Redmond, WA, and in 2010, became part of Olympus Medical Systems Corp. Spiration Inc.-Olympus Respiratory America will continue its mission to be a pioneer in the field of lung therapy.
Spiration is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, sexual orientation, gender identity, disability or protected veteran status.
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