Join Our Team and Shape the Future of Medical Device Regulation
We are seeking an experienced and strategic Associate Director, Regulatory Affairs to lead our regulatory efforts and ensure compliance with global regulatory requirements, with a focus on the European Union Medical Device Regulation (EU MDR 2017/745). As a key member of our team, you will develop and implement regulatory strategies, manage regulatory submissions, and collaborate with cross-functional teams to drive business objectives.
About the Role:
The Associate Director, Regulatory Affairs will play a critical leadership role in ensuring our medical devices comply with global regulatory requirements. This position will be responsible for developing and implementing regulatory strategies, managing regulatory submissions, and ensuring ongoing compliance to support product lifecycle management, market access, and business objectives. The successful candidate will have deep expertise in MDR requirements and a strong ability to manage regulatory challenges while fostering a culture of compliance and continuous improvement.
Key Responsibilities:
- Develop and implement comprehensive regulatory strategies to support CE marking under the EU Medical Device Regulation (MDR 2017/745) for our medical device portfolio.
- Ensure compliance with global regulatory requirements, including ISO 13485, FDA 21 CFR Part 820, and other applicable standards and regulations.
- Lead the preparation, submission, and maintenance of regulatory documentation, including Technical Documentation and General Safety and Performance Requirements (GSPR).
- Collaborate with cross-functional teams, including R&D, Quality Assurance, Clinical Affairs, and Manufacturing, to provide regulatory input during product development, design changes, and post-market activities.
- Oversee regulatory submissions for CE marking and potentially other global markets, ensuring timely approval of new and existing products.
- Monitor, interpret, and communicate regulatory changes, trends, and guidance to ensure the organization remains proactive in compliance.
What We Offer:
- A competitive salary range of $128,373 - $214,029.
- A comprehensive and competitive range of benefits, including a generous 401(k) employer match.
- Opportunities for professional growth and development in a dynamic and innovative company.
- A collaborative and supportive work environment with a team of experienced professionals.
Requirements:
- Bachelor's degree in a relevant scientific, engineering, or medical discipline.
- Advanced degree (e.g., Master's, Ph.D.) in a related field is preferred.
- Regulatory Affairs Certification (RAC) or similar professional certification is a plus.
- A minimum of 8 years of experience in regulatory affairs within the medical device industry, or 5 years with an advanced degree, and with at least 3-5 years in a leadership or management role.
- Extensive experience with EU MDR 2017/745, including technical documentation, clinical evaluation requirements, conformity assessments, and post-market surveillance processes.
How to Apply:
If you are a motivated and experienced regulatory professional looking for a new challenge, please submit your application, including your resume and a cover letter, to Apply Now. We look forward to hearing from you.
Apply Now