Senior Regulatory Affairs Project Manager

Salary/Rate:65,000EUR - 80,000EUR depeding on experience
Job type:Perm
Business Sectors:Regulatory Affairs, R&D
Job ref:25238
Post Date:04. 06. 2024

About the Role

Senior Regulatory Affairs Project Manager (m/f/d)

Location: Aachen, Germany| Hybrid

Our client is a medical technology company from Aachen dedicated to providing patients across the world with their much-needed Class III medical devices.

  1. Attractive Remuneration: Benefit from a competitive salary package that reflects your skills and contributions, rewarding you generously for your hard work.
  2. Flexible Work Options: Take advantage of the opportunity to work from home 4 days per week, offering a perfect balance between professional productivity and personal comfort.
  3. Generous Vacation Policy: Recharge and rejuvenate with 30 days of vacation per year, giving you ample time to relax and enjoy life outside of work.
  4. Permanent Full-Time Position: Secure a long-term career with a full-time position that offers stability, growth, and the potential to advance within the company.
  5. Continuous Learning and Development: Enhance your skills and knowledge through regular training and further education opportunities, fostering your personal and professional growth.
  6. Monthly Benefits: Enjoy a monthly socials and an attractive employee participation program.

As the Senior Regulatory Affairs Project Manager, your role encompasses driving the development, registration, and market entry of their core product, while also acting as the primary contact for regulatory issues among both their team and external partners.
You will be tasked with formulating and executing strategies to adhere to regulatory requirements, overseeing everything from strategic planning to the preparation of technical documentation in collaboration with their internal and external teams.
Since our client are a small team, you will be also required to write regulatory documents yourself for the initial period. Additionally, you will negotiate agreements with partners and suppliers, ensuring our operations align with quality management standards set forth by ISO 13485 and 21 CFR 820.

Your Profile:

• Motivation and enjoyment of work – especially in medical technology and development• Strong ownership, drive, independence and commitment
• Proven leadership capabilities
• Technical or scientific degree or comparable training
• Several years of professional experience in the medical device sector, preferably in product management, RA and project management including contact with regulatory bodies
• Preferably experienced in applying ISO 13485, ISO 14971, 21 CFR 820, and MDR
• Confident handling of Microsoft Office and proficient English in spoken and written form

To apply or for more information please contact Luke via email on:                #LI-Hybrid #LI-LF1