Are you a seasoned quality and regulatory leader looking to drive compliance and innovation in the medical device industry? We are seeking a Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, to oversee regulatory strategy, ensure compliance with industry standards, and maintain the highest quality standards for medical devices. This executive role requires a highly skilled professional with extensive experience in regulatory affairs, quality management systems (QMS), and compliance with FDA, ISO, and global medical device regulations.

As the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, you will play a critical role in leading regulatory submissions, managing audits, and implementing quality assurance programs that drive operational excellence. If you have a proven track record in regulatory leadership and thrive in a fast-paced, high-stakes environment, this is an excellent opportunity to contribute to a company at the forefront of medical device innovation.

About This Role

The Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA will be responsible for developing and executing strategies to ensure regulatory compliance and product quality. This role will require deep expertise in FDA regulations, ISO 13485 standards, and other global regulatory frameworks governing the medical device industry. The ideal candidate will be a proactive leader capable of navigating complex regulatory landscapes, managing risk, and driving continuous quality improvement initiatives.

In this position, you will oversee regulatory filings, manage quality audits, and work closely with cross-functional teams to ensure compliance at all levels. As the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, you will serve as a key liaison with regulatory agencies, develop and maintain company-wide quality management systems, and lead efforts to ensure that all medical device products meet safety and efficacy standards. Your leadership will be instrumental in securing regulatory approvals and maintaining the highest level of quality across all products and processes.

Key Responsibilities – Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA

Develop and Implement Regulatory Strategy

Define and execute regulatory strategies to ensure compliance with FDA, ISO, and other global regulatory requirements.
Monitor regulatory changes and proactively adjust company policies and procedures to remain compliant.
Serve as the primary point of contact with regulatory agencies, managing communication and submissions.

Oversee Quality Management Systems (QMS)

Lead the development, implementation, and maintenance of a robust QMS that meets ISO 13485 and FDA QSR requirements.
Ensure company-wide adherence to quality policies and procedures.
Conduct internal audits and drive continuous improvements to enhance QMS effectiveness.

Manage Regulatory Submissions and Approvals

Oversee the preparation and submission of regulatory filings, including 510(k)s, PMAs, and CE mark applications.
Collaborate with R&D and engineering teams to ensure regulatory requirements are integrated into product development.
Address regulatory questions and provide strategic guidance on product approvals.

Ensure Compliance with Industry Standards and Regulations

Maintain up-to-date knowledge of FDA, EU MDR, Health Canada, and other international regulatory requirements.
Develop and implement compliance training programs for employees at all levels.
Establish procedures to proactively identify and mitigate regulatory risks.

Lead Internal and External Audits

Manage and coordinate FDA, ISO, and other regulatory audits and inspections.
Prepare documentation and responses to audit findings to ensure continued compliance.
Work with third-party auditors and certification bodies to maintain required approvals and certifications.

Drive Risk Management and Quality Assurance

Oversee the risk management program in compliance with ISO 14971.
Develop risk mitigation strategies for product development and manufacturing processes.
Ensure product safety and efficacy through rigorous quality assurance testing and validation.

Support Product Development and Market Expansion

Collaborate with R&D, clinical, and commercial teams to integrate regulatory requirements into product designs.
Provide guidance on regulatory pathways for new products and modifications to existing devices.
Assist in global market expansion by ensuring compliance with international regulatory requirements.

Build and Lead a High-Performing Regulatory and Quality Team

Recruit, mentor, and lead a team of quality and regulatory professionals.
Foster a culture of regulatory excellence and continuous improvement.
Provide ongoing training and development to ensure regulatory and quality teams remain at the forefront of industry standards.

What The Client is Looking For in You

To excel as the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, you must bring a combination of technical expertise, leadership skills, and a strong understanding of regulatory requirements. The ideal candidate will have:

Extensive Experience in Regulatory Affairs and Quality Management

A deep understanding of FDA, ISO 13485, EU MDR, and other global regulatory requirements.
Proven track record of leading regulatory submissions, quality audits, and compliance programs.
Experience managing 510(k) submissions, PMAs, CE mark applications, and Health Canada filings.

Strategic Leadership and Decision-Making Skills

The ability to develop and execute regulatory and quality strategies that align with business objectives.
Experience leading cross-functional teams and influencing company-wide quality and compliance culture.
Strong decision-making skills to navigate complex regulatory landscapes and mitigate risks.

Proven Ability to Handle Audits and Compliance Processes

Experience managing FDA inspections, ISO audits, and third-party compliance reviews.
Strong problem-solving skills to address compliance gaps and implement corrective actions.
Ability to work proactively with regulatory agencies and maintain strong professional relationships.

Strong Communication and Collaboration Skills

Ability to communicate complex regulatory requirements to internal teams, executives, and stakeholders.
Experience working cross-functionally with R&D, clinical, marketing, and manufacturing teams.
Leadership in training and educating staff on quality and regulatory best practices.

Educational and Professional Background

Bachelor’s or Master’s degree in Regulatory Affairs, Quality Assurance, Biomedical Engineering, or a related field.
RAC (Regulatory Affairs Certification) or ASQ (American Society for Quality) certifications are preferred.
Minimum of 10+ years of experience in regulatory affairs and quality management within the medical device industry.

Why This Opportunity Stands Out

This is a unique opportunity to be a key leader in a growing medical device company, ensuring regulatory excellence and quality across all products. As the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, you will:

Play a Mission-Critical Role – Your leadership will directly impact the company’s ability to bring life-saving medical devices to market while ensuring patient safety.
Be Part of an Innovative and Fast-Growing Organization – Join a company that is expanding its medical device portfolio and making a difference in healthcare.
Lead Regulatory and Quality Strategy at an Executive Level – Work closely with the CEO, COO, and product development teams to shape the company’s regulatory and quality roadmap.
Competitive Compensation and Benefits – Receive a highly competitive salary, performance-based bonuses, and comprehensive benefits, including healthcare, 401(k), and professional development opportunities.
Work in a Collaborative and High-Impact Environment – Be part of a company culture that values integrity, innovation, and teamwork.
Global Market Expansion – Lead regulatory and quality efforts as the company scales its products into international markets.
Opportunity for Career Growth – Advance within a company that values its leadership team and invests in professional development.

FAQs About the Role

Q: What industries should I have experience in?
A: Candidates should have a strong background in the medical device industry, with experience in regulatory affairs, quality management systems, and compliance with FDA and ISO standards.

Q: Is relocation required for this position?
A: This role is based in Seattle, WA. Candidates must be open to relocation or already reside in the area.

Q: What are the key regulatory certifications and standards required?
A: Candidates should be well-versed in FDA regulations, ISO 13485, EU MDR, and Health Canada requirements. RAC or ASQ certifications are preferred.

Q: What type of leadership style is expected?
A: We are looking for a strategic and proactive leader who can drive compliance initiatives, mentor teams, and collaborate effectively with executives and regulatory agencies.

Q: What is the expected travel requirement?
A: This role may require occasional travel for regulatory meetings, audits, and industry conferences.

Q: What is the timeline for hiring and onboarding?
A: The company is actively seeking the right candidate and aims to complete the hiring process within the next 60–90 days. Onboarding will include training on company processes, regulatory strategy meetings, and alignment with leadership teams.

Q: What are the key success factors for this role?
A: Success in this role will be measured by the ability to maintain regulatory compliance, secure product approvals, lead successful audits, and enhance the company’s quality management system.

Q: What opportunities for professional growth does this role offer?
A: This role provides opportunities to expand into senior executive leadership, oversee global regulatory operations, and contribute to the strategic direction of the company’s medical device portfolio.

What Remuneration Can You Expect from This Job?

As the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA, you can expect a highly competitive compensation package that reflects your leadership role and expertise in regulatory compliance and quality management. The base salary for this position typically ranges from $180,000 – $230,000 per year, depending on experience, qualifications, and industry track record.

In addition to the base salary, this role includes performance-based bonuses tied to key regulatory milestones, successful audits, and product approvals. Equity options or stock grants may be available, offering the opportunity to share in the company’s long-term success.

The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), 401(k) retirement plans with company matching, paid time off, and professional development opportunities, such as RAC or ASQ certification sponsorships and industry conference participation. Additional perks may include relocation assistance, travel allowances, and executive leadership training programs.

This position offers not just a strong financial package but also the opportunity to make a significant impact in the medical device industry while leading regulatory and quality strategies in a growing company.

How to Apply for This Director of Quality and Regulatory Affairs (Medical Device) Position in Seattle, WA

If you are an experienced regulatory and quality leader with a proven track record in the medical device industry, we invite you to apply for the Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA. This is an outstanding opportunity to lead compliance initiatives, ensure product approvals, and shape the future of medical device innovations.

To apply, please submit your resume and a cover letter detailing your expertise in regulatory affairs, quality management systems, and compliance leadership within the medical device sector.

This role provides a rewarding opportunity to drive regulatory excellence, oversee quality processes, and contribute to a company that is committed to delivering cutting-edge medical technologies. Apply today to take the next step in your leadership career as a Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA!

For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.

Tags:

Job Category: Director of Quality and Regulatory Affairs

Job Type: Full Time

Job Location: Seattle

Director of Quality and Regulatory Affairs (Medical Device) in Seattle, WA