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For Companies At a Glance
- Tasks: Lead regulatory strategies for innovative medical devices and ensure compliance with global standards.
- Company: Join a cutting-edge medical tech company dedicated to improving patient care through advanced technologies.
- Benefits: Enjoy a full-time role with opportunities for professional growth and collaboration in a dynamic environment.
- Why this job: Be at the forefront of healthcare innovation, making a real impact on patient lives and safety.
- Qualifications: 10+ years in regulatory affairs, with proven success in FDA submissions and medical device experience.
- Other info: This role is based in Boston, MA, offering a chance to work with top industry professionals.
The predicted salary is between 72000 - 108000 £ per year.
Overview
We are a growing medical technology company focused on developing innovative technologies that improve patient care. Our work combines advanced software, hardware, and AI to deliver safe, reliable, and impactful healthcare solutions.
We are looking for an experienced Regulatory Affairs leader to lead our journey to FDA approval. This position is focused on ensuring global regulatory approvals, embedding compliance processes across the organization, and building strong relationships with authorities to support market entry and ongoing product lifecycle needs.
Responsibilities
- Create and drive worldwide regulatory strategies for new and existing devices, including software solutions.
- Prepare and submit applications such as 510(k), IDE, PMA, CE files, design dossiers, and international registrations.
- Act as the primary point of contact with regulators and notified bodies.
- Integrate regulatory requirements into development, manufacturing, and commercialization activities.
- Review design modifications, risk assessments, clinical documentation, and promotional content for compliance.
- Lead reporting activities for incidents, complaints, and corrective actions.
- Support both internal and external inspections, including FDA and ISO 13485 audits.
- Manage regulatory oversight throughout the product lifecycle, including changes and updates.
- Collaborate with teams across research, product design, operations, quality, clinical, and marketing.
- Monitor regulatory landscape changes and update internal quality systems accordingly.
Qualifications
- At least 10 years of regulatory affairs experience in the medical device field.
- Demonstrated success with FDA submissions.
- Background in Class II/III medical devices.
- Experience developing regulatory strategies for novel or advanced healthcare technologies.
- Direct experience working with FDA and other international bodies.
- Deep understanding of FDA QSR, ISO 13485 and relevant standards.
- Strong leadership, communication, and project management abilities.
The role is based in Boston, MA.
Seniority
- Director
Employment type
- Full-time
Job function
- Research
Industries
- Medical Equipment Manufacturing
- Biotechnology Research
- Hospitals and Health Care
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Director of Regulatory Affairs employer: Stealth Startup
Contact Detail:
Stealth Startup Recruiting Team
StudySmarter Expert Advice 🤫
We think this is how you could land Director of Regulatory Affairs
✨Tip Number 1
Network with professionals in the regulatory affairs field, especially those who have experience with FDA submissions. Attend industry conferences and seminars to meet potential colleagues and learn about the latest trends and challenges in medical device regulations.
✨Tip Number 2
Familiarise yourself with the specific regulatory requirements for Class II/III medical devices. Understanding the nuances of these classifications will help you demonstrate your expertise during interviews and discussions with our team.
✨Tip Number 3
Prepare to discuss your previous successes in obtaining regulatory approvals. Be ready to share specific examples of how you developed and implemented regulatory strategies that led to successful submissions, as this will showcase your capability to lead our regulatory efforts.
✨Tip Number 4
Stay updated on changes in the regulatory landscape, particularly those affecting medical technology. Being knowledgeable about recent developments will not only enhance your conversations with us but also show your commitment to staying at the forefront of the industry.
We think you need these skills to ace Director of Regulatory Affairs
Some tips for your application 🫡
Tailor Your CV: Make sure your CV highlights your extensive experience in regulatory affairs, particularly in the medical device field. Emphasise your successes with FDA submissions and any relevant leadership roles you've held.
Craft a Compelling Cover Letter: In your cover letter, clearly articulate your passion for improving patient care through innovative technologies. Discuss your experience with regulatory strategies and how you can contribute to the company's mission.
Highlight Relevant Experience: When detailing your work history, focus on specific projects where you successfully navigated regulatory approvals. Mention your familiarity with FDA QSR, ISO 13485, and your ability to manage compliance processes.
Showcase Leadership Skills: Since this is a director-level position, be sure to highlight your leadership and project management abilities. Provide examples of how you've led teams or initiatives that resulted in successful regulatory outcomes.
How to prepare for a job interview at Stealth Startup
✨Showcase Your Regulatory Expertise
Make sure to highlight your extensive experience in regulatory affairs, especially with FDA submissions. Be prepared to discuss specific examples of successful applications you've managed, particularly for Class II/III medical devices.
✨Demonstrate Strategic Thinking
Discuss how you have developed and implemented regulatory strategies in the past. Emphasise your ability to integrate regulatory requirements into product development and how this has positively impacted market entry and compliance.
✨Build Rapport with Regulators
Since the role involves acting as a primary contact with regulators, share your experiences in building strong relationships with authorities. Highlight any successful collaborations that led to smoother approval processes or inspections.
✨Stay Updated on Regulatory Changes
Show your awareness of the evolving regulatory landscape by discussing recent changes in regulations that could impact the medical device industry. This demonstrates your commitment to continuous learning and adaptability in your role.
