Are you a seasoned regulatory affairs professional with a passion for the medical device industry? We are looking for a Regulatory Affairs Specialist Manager (Med Device) in Portland, OR to lead and oversee all regulatory processes related to medical devices. In this role, you will be a key player in ensuring that products meet regulatory requirements for approval and are compliant with local and international standards. If you are an experienced regulatory expert with a background in medical devices, this opportunity could be the next step in your career.
About The Role
As the Regulatory Affairs Specialist Manager (Med Device) in Portland, OR, you will be responsible for managing regulatory submissions, maintaining compliance with medical device regulations, and leading regulatory strategy. Your role will be critical in ensuring that medical devices are approved for the market and that all regulatory submissions meet the necessary standards. You will work closely with cross-functional teams to navigate complex regulatory requirements, manage risk, and support product development and market entry. This position offers the chance to make a significant impact in a rapidly growing and innovative field.
Key Responsibilities – Regulatory Affairs Specialist Manager (Med Device) in Portland, OR
Manage Regulatory Submissions
- Lead regulatory submissions for new medical devices and product changes to ensure timely approval.
- Prepare and submit regulatory documentation, including 510(k), PMA, and CE mark applications.
- Collaborate with internal teams to ensure all regulatory requirements are met for product approvals.
Oversee Compliance with Regulations
- Ensure compliance with FDA, ISO, and other regulatory agencies’ standards for medical devices.
- Monitor and interpret changes in regulations and advise teams on their impact on product development.
- Implement strategies to ensure ongoing compliance throughout the product lifecycle.
Develop Regulatory Strategy
- Develop regulatory strategies for new medical device products, including market access and approval pathways.
- Work with product development and marketing teams to define regulatory approaches for new products.
- Ensure regulatory strategies align with company goals and objectives.
Coordinate Cross-Functional Teams
- Collaborate with R&D, quality assurance, and manufacturing teams to ensure compliance with regulatory requirements.
- Provide regulatory guidance to cross-functional teams throughout product development.
- Coordinate with clinical affairs and quality control to ensure all product documentation is compliant.
Lead Regulatory Documentation and Reporting
- Ensure all regulatory filings and submissions are completed accurately and in accordance with required timelines.
- Maintain accurate records of all regulatory correspondence, approvals, and product changes.
- Manage regulatory documentation for ongoing product lifecycle management.
Support Global Market Expansion
- Assist with regulatory approvals for international markets, ensuring compliance with global standards.
- Develop strategies to navigate international regulations, including those for the EU, Asia, and other key regions.
- Provide regulatory expertise to support the company’s global product launches.
Provide Regulatory Risk Management
- Identify and assess regulatory risks associated with product development and market approval.
- Develop mitigation strategies to address regulatory challenges and reduce risk.
- Advise senior management on regulatory risks and provide solutions to overcome obstacles.
Maintain Knowledge of Regulatory Trends
- Stay updated on the latest regulatory trends, changes in legislation, and best practices in the medical device industry.
- Attend regulatory workshops, seminars, and conferences to maintain expertise in the field.
- Share regulatory insights with internal teams to ensure compliance and strategic alignment.
What The Client is Looking For in You
The ideal candidate for the Regulatory Affairs Specialist Manager (Med Device) in Portland, OR position will possess a strong background in regulatory affairs within the medical device industry. You should bring a combination of technical expertise, leadership abilities, and strategic thinking to the role. Specifically, the client is looking for:
- Extensive Experience in Medical Device Regulatory Affairs – A proven track record of regulatory submissions and approvals for medical devices, with experience in FDA, CE mark, and international regulations.
- Leadership and Team Collaboration – Strong leadership skills with the ability to lead cross-functional teams and ensure compliance with complex regulatory requirements.
- Strategic Regulatory Insight – The ability to develop and implement regulatory strategies that support the company’s goals, including navigating changes in regulations and market conditions.
- Problem-Solving and Risk Management – Experience identifying and mitigating regulatory risks, offering solutions to overcome challenges.
- Global Regulatory Expertise – Knowledge of international regulatory requirements for medical devices, ensuring market access and compliance across various regions.
Why This Opportunity Stands Out
This position offers a unique opportunity to take on a leadership role in the highly impactful field of regulatory affairs within the medical device industry. The Regulatory Affairs Specialist Manager (Med Device) in Portland, OR role stands out for several reasons:
- Career Growth – This role offers excellent growth potential, with the chance to shape the company’s regulatory strategy and lead a critical function that directly impacts the success of new medical devices in the market.
- Impactful Work – You will play a key role in ensuring that life-changing medical devices reach the market, improving patient care and outcomes.
- Collaborative Environment – The role provides an opportunity to work with diverse, cross-functional teams, including R&D, quality assurance, and manufacturing, to drive product compliance and regulatory success.
- Competitive Compensation – The position offers a competitive salary and benefits package, including opportunities for performance-based bonuses and professional development.
FAQs About the Role
Q: What industries should I have experience in?
A: You should have experience in regulatory affairs for medical devices, particularly with FDA and international regulatory standards, as well as knowledge of ISO standards for medical device manufacturing.
Q: Is relocation required for this position?
A: The role is based in Portland, OR. Candidates must either be local or willing to relocate. A relocation package may be available for the right candidate.
Q: What is the reporting structure for this role?
A: The Regulatory Affairs Specialist Manager (Med Device) will report directly to the Director of Regulatory Affairs and work closely with the R&D, quality assurance, and executive leadership teams.
Q: What kind of leadership style is expected?
A: The ideal candidate should have a collaborative and results-driven leadership style, with the ability to work cross-functionally, mentor team members, and ensure compliance across all product development stages.
Q: What is the expected travel requirement?
A: Some travel may be required for supplier visits, regulatory inspections, and industry events, but most responsibilities will be carried out from the Portland, OR office.
Q: What qualifications and skills are required?
A: Candidates should have a degree in life sciences, regulatory affairs, or a related field, along with at least 5-7 years of experience in regulatory affairs in the medical device industry. A RAC (Regulatory Affairs Certification) is a plus.
Q: How does this role contribute to the company’s success?
A: This role ensures the timely approval and compliance of medical devices, allowing the company to bring innovative products to market, driving growth and improving patient outcomes.
Q: What is the timeline for hiring and onboarding?
A: The company aims to fill this role within the next 60–90 days. Onboarding will include training on company products, regulatory procedures, and integration with cross-functional teams.
What Remuneration Can You Expect from This Job?
As the Regulatory Affairs Specialist Manager (Med Device) in Portland, OR, you can expect a highly competitive compensation package designed to attract top-tier professionals in the regulatory field. The base salary for this role typically ranges from $100,000 to $130,000 per year, depending on factors such as your years of experience, regulatory expertise, and relevant industry qualifications.
Beyond the base salary, this position offers performance-based bonuses that are linked to key regulatory milestones, such as successful product approvals and meeting regulatory submission deadlines. The company highly values employees who drive the successful launch of medical devices and meet regulatory goals, and they reward those contributions generously.
The benefits package is robust and comprehensive, offering health insurance coverage (medical, dental, and vision), a 401(k) retirement plan with company matching contributions, paid time off (PTO), and access to professional development programs. The company also fosters career growth by offering opportunities for continued learning and skill enhancement, which is especially valuable in the fast-evolving medical device sector.
For high-performing candidates, stock options or equity grants may also be available, giving you the potential to benefit from the company’s long-term growth and success. This role provides not just a competitive salary but also an exciting opportunity for both personal and professional growth in a highly impactful, cutting-edge industry that contributes directly to the global healthcare sector.
How to Apply for This Regulatory Affairs Specialist Manager (Med Device) Position in Portland, OR
If you are a skilled and experienced regulatory affairs professional with a passion for the medical device industry, we invite you to apply for the Regulatory Affairs Specialist Manager (Med Device) role in Portland, OR. This is a great opportunity to lead regulatory strategies and ensure compliance for life-changing medical devices.
To apply, please submit your resume along with a cover letter that highlights your regulatory experience, leadership skills, and knowledge of FDA and international regulatory requirements.
This role offers an exciting opportunity to make a significant impact in the medical device industry while working with a dynamic team committed to innovation and excellence. Apply today and take the next step in your regulatory affairs career!
For more information or to explore similar opportunities, visit our Medical Device Recruiters page.
Tags: Regulatory Affairs Manager | Medical Device Regulatory Affairs | FDA Compliance | Regulatory Affairs Specialist | Portland, OR Regulatory Jobs | Medical Device Industry
