Are you a skilled medical writer with a passion for translating complex clinical data into clear, compelling regulatory documents? We are seeking a Director of Medical Writing (Medical Device) in Seattle, WA, to lead and oversee the development of high-quality clinical and regulatory documents. This executive role requires a professional with extensive experience in medical writing, regulatory submissions, and document strategy within the medical device industry.
As the Director of Medical Writing (Medical Device) in Seattle, WA, you will play a pivotal role in ensuring compliance with global regulatory standards while shaping the company’s scientific communications. This position is ideal for a detail-oriented leader who excels in managing cross-functional teams, developing submission-ready documentation, and streamlining medical writing processes. If you have a strong background in clinical writing, regulatory submissions, and scientific storytelling, we encourage you to apply for this exciting leadership opportunity.
About This Role
The Director of Medical Writing (Medical Device) in Seattle, WA is responsible for overseeing all aspects of medical writing, ensuring the development of clear, scientifically accurate, and regulatory-compliant documents. This role requires a deep understanding of regulatory frameworks, clinical trial documentation, and technical writing principles within the medical device industry.
As the Director of Medical Writing (Medical Device) in Seattle, WA, you will collaborate with clinical, regulatory, and scientific teams to create high-impact content for regulatory submissions, clinical study reports, and investigator brochures. Your expertise in structuring complex medical information and managing document lifecycles will be crucial in supporting product approvals and market expansion. This is an exciting opportunity to lead a high-performing team, implement best practices, and contribute to the advancement of medical technologies that improve patient outcomes.
Key Responsibilities – Director of Medical Writing (Medical Device) in Seattle, WA
1. Lead the Medical Writing Department
- Oversee the medical writing function, ensuring high-quality and timely delivery of regulatory and clinical documents.
- Develop and implement best practices for document development, review, and submission.
- Provide strategic guidance to the medical writing team and collaborate with leadership on communication strategies.
2. Develop Regulatory Submission Documents
- Create and oversee the development of clinical study reports (CSRs), investigator brochures (IBs), and clinical evaluation reports (CERs).
- Ensure alignment with FDA, EMA, and other global regulatory requirements.
- Manage document templates, version control, and submission timelines for regulatory filings.
3. Collaborate with Cross-Functional Teams
- Work closely with clinical, regulatory, and R&D teams to gather scientific data and ensure accurate reporting.
- Coordinate with external stakeholders, including regulatory agencies and contract research organizations (CROs).
- Facilitate team discussions to ensure consistency in messaging and compliance with industry standards.
4. Ensure Scientific and Regulatory Accuracy
- Review and edit clinical and regulatory documents to maintain high scientific integrity.
- Stay updated on industry trends, regulatory guidelines, and evolving medical device documentation standards.
- Conduct internal audits of medical writing processes to ensure accuracy and compliance.
5. Manage Document Lifecycles and Version Control
- Oversee the tracking, updating, and archiving of all medical writing documentation.
- Implement version control best practices to maintain consistency across multiple submissions.
- Ensure seamless coordination of document reviews, approvals, and finalization.
6. Train and Mentor Medical Writing Team Members
- Provide leadership, mentorship, and training to junior medical writers and other team members.
- Develop and implement training programs to enhance the team’s understanding of regulatory writing principles.
- Foster a collaborative environment that encourages knowledge-sharing and continuous learning.
7. Drive Process Improvements in Medical Writing
- Identify and implement innovative strategies to improve efficiency and quality in medical writing processes.
- Optimize workflows for document preparation, review, and approval.
- Utilize technology and automation tools to streamline medical writing activities.
8. Support Marketing and Scientific Communications
- Assist in the development of scientific publications, white papers, and educational materials.
- Work with marketing teams to ensure alignment between regulatory and promotional messaging.
- Provide expertise in data interpretation and scientific storytelling for external communications.
What The Client is Looking For in You
To excel as the Director of Medical Writing (Medical Device) in Seattle, WA, you should bring a combination of strategic leadership, regulatory expertise, and exceptional writing skills. The ideal candidate will possess:
- Extensive Experience in Medical Writing – At least 8-10 years of experience in medical writing within the medical device, pharmaceutical, or biotechnology industry.
- Regulatory & Compliance Expertise – Strong knowledge of global regulatory requirements, including FDA, EMA, and ISO standards related to medical device submissions.
- Exceptional Scientific Communication Skills – Ability to translate complex clinical and scientific data into clear, precise, and engaging regulatory and clinical documents.
- Strategic Leadership & Team Management – Proven ability to lead and mentor a medical writing team, ensuring high-quality documentation and regulatory compliance.
- Collaboration with Cross-Functional Teams – Experience working with regulatory affairs, clinical research, R&D, and marketing teams to develop cohesive messaging strategies.
- Attention to Detail & Quality Focus – A meticulous approach to document development, ensuring accuracy, consistency, and alignment with regulatory expectations.
- Project Management & Deadline Execution – Strong ability to manage multiple projects, prioritize deadlines, and deliver high-quality work under tight timelines.
- Advanced Degree in Life Sciences or Related Field – A Master’s or Ph.D. in a scientific discipline (e.g., Biomedical Science, Pharmacology, or Medical Writing) is preferred.
Why This Opportunity Stands Out
This role is an exciting opportunity to take your medical writing career to the next level. As the Director of Medical Writing (Medical Device) in Seattle, WA, you will:
- Lead a Critical Function in a High-Growth Industry – Medical writing plays a vital role in regulatory approvals, making this position essential for bringing innovative medical devices to market.
- Work in a Collaborative & Impactful Environment – Join a company that values scientific integrity, teamwork, and innovation in medical technology.
- Competitive Compensation & Benefits – Receive a strong salary package, performance-based bonuses, and executive-level perks.
- Career Growth & Leadership Development – This position offers significant professional development, with opportunities to lead strategic projects and build high-performing teams.
- Influence Regulatory & Clinical Strategy – Play a key role in shaping how clinical data is communicated to regulators, healthcare professionals, and stakeholders.
- Join a Forward-Thinking Organization – Work with cutting-edge medical devices that have the potential to improve patient outcomes worldwide.
FAQs About the Role
Q: What type of medical devices will I be working with?
A: You will be working on a range of medical devices, including Class II and Class III devices, with a focus on regulatory submissions, clinical studies, and post-market reporting.
Q: Does this role require previous experience in the medical device industry?
A: Yes, candidates should have direct experience in medical writing for medical devices, including clinical and regulatory documentation.
Q: What are the key regulatory frameworks I should be familiar with?
A: Strong knowledge of FDA 510(k) and PMA submissions, EU MDR requirements, and global regulatory standards is essential for success in this role.
Q: Will I be managing a team, and if so, how large?
A: Yes, this role involves leading a team of medical writers, regulatory specialists, and external consultants, depending on project needs.
Q: Is relocation required for this position?
A: The role is based in Seattle, WA. Candidates should be open to relocating or already reside in the area.
Q: What is the expected travel requirement for this position?
A: Minimal travel may be required for industry conferences, regulatory meetings, and internal team collaborations.
Q: What software or tools should I be proficient in?
A: Familiarity with regulatory writing tools, content management systems, and statistical software for clinical data analysis is a plus.
Q: What is the timeline for hiring and onboarding?
A: The company aims to hire within 60–90 days, with a structured onboarding process that includes training on company workflows and regulatory documentation strategies.
What Remuneration Can You Expect from This Job?
As the Director of Medical Writing (Medical Device) in Seattle, WA, you can expect a highly competitive compensation package that reflects your expertise, leadership, and contribution to regulatory success. The base salary for this role typically ranges from $160,000 – $210,000 per year, depending on experience, industry knowledge, and past achievements in medical writing and regulatory affairs.
Beyond the base salary, this position includes performance-based bonuses tied to key deliverables such as successful regulatory submissions, clinical documentation quality, and team leadership. Equity options or stock grants may also be available for the right candidate, providing an opportunity to share in the company’s long-term success.
The benefits package includes comprehensive healthcare coverage (medical, dental, and vision), a 401(k) retirement plan with company matching, executive-level perks, paid time off, and professional development opportunities such as industry conferences and regulatory training programs. Additional benefits may include a relocation package, flexible work arrangements, and tuition reimbursement for continuing education.
This role offers a lucrative financial package along with the opportunity to lead a high-impact medical writing team, influence regulatory strategies, and contribute to groundbreaking medical advancements in a rapidly evolving industry.
How to Apply for This Director of Medical Writing (Medical Device) Position in Seattle, WA
If you are a skilled and strategic leader in medical writing with expertise in regulatory and clinical documentation, we invite you to apply for the Director of Medical Writing (Medical Device) in Seattle, WA. This is an exceptional opportunity to drive regulatory success, enhance medical communication strategies, and contribute to the commercialization of innovative medical devices.
To apply, please submit your resume and a cover letter detailing your experience in regulatory submissions, clinical documentation, and leadership within medical writing teams.
This role offers a rewarding opportunity to work alongside industry experts, shape critical regulatory strategies, and contribute to a company dedicated to improving healthcare solutions. Apply today to take the next step in your executive career as a Director of Medical Writing (Medical Device) in Seattle, WA!
For more information or to explore similar opportunities, visit our Medical Device Recruiters Page.
Tags:
Director of Medical Writing | Medical Device Medical Writing | Regulatory Affairs Writing | Clinical Documentation | FDA Submissions
