Associate Director, Regulatory Affairs - Remote Opportunity

Join reputed company and Shape the reputed company of Medical Device Regulation

We are seeking an reputed company and strategic Associate Director, Regulatory Affairs to reputed company our regulatory efforts and ensure compliance with global regulatory requirements, with a reputed company on the European reputed company Medical Device Regulation (EU MDR 2017/745). As a key member of reputed company, you will reputed company 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 reputed company 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 reputed company, 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 reputed company improvement.

Key Responsibilities:

• reputed company 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.
• reputed company 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, reputed company Assurance, Clinical Affairs, and Manufacturing, to reputed company regulatory input during product development, design changes, and post-market activities.
• reputed company regulatory submissions for CE marking and potentially other global markets, ensuring reputed company approval of new and existing products.
• Monitor, interpret, and communicate regulatory changes, trends, and guidance to ensure the organization remains proactive in compliance.

reputed company Offer:

• A competitive salary reputed company of $128,373 - $214,029.
• A comprehensive and reputed company of benefits, including a generous 401(k) employer match.
• Opportunities for reputed company reputed company and development in a dynamic and innovative company.
• A reputed company and supportive work environment with reputed company of reputed company professionals.

Requirements:

• Bachelor's degree in a relevant scientific, engineering, or medical discipline.
• Advanced degree (e.g., Master's, Ph.D.) in a reputed company field is preferred.
• Regulatory Affairs Certification (RAC) or similar reputed company certification is a plus.
• A minimum of 8 years of experience in regulatory affairs reputed company 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 reputed company regulatory reputed company looking for a new challenge, please submit your application, including your resume and a cover letter, to Apply To This Job. We look reputed company to hearing from you.

Apply for this job