Our client are a leading company in eyecare with the mission of allowing patients to the best vision and to be the championing force for innovation in ophthalmology. This is an opportunity to be part of a team that goes above and beyond to improve the everyday lives of so many people around the world.
As a Regulatory Affairs Manager based in Erlangen, you are responsible for interpreting regulations as they apply to ophthalmic refractive surgery equipment and software practices and procedures as well as investigating and resolving compliance problems, questions received from other units of the company, customers, government regulatory agencies and any stakeholders involved.
- Prepare technical files and manage execution of submissions to Notified Bodies and Regulatory Authorities.
- Manage execution of submissions in accordance with regulatory plans and timelines.
- Providing strategic registration direction on interaction and negotiating evidence with regulatory agencies
- Support all other departments and external stakeholders with regulatory issues.
- Serving as a regulatory liaison on the project team throughout the product lifecycle
- Support the regulatory department to ensure efficient and compliant business processes and coordinate operating procedures within a cross-functional team.
- Master’s Degree in Science/Engineering or equivalent working experience.
- 6 years of working experience in Regulatory Affairs role within a Medical Device manufacturer or ISO 13485 certified environment.
- Experience writing technical files for MDR, FDA and Health Canada submissions. Experience working with PMA’s would be a significant advantage.
- Professional experience with active devices is ideal, experience with lasers would be am added advantage.
- Fluency in English is essential, fluency in German is also strongly preferred.
What they offer
- You get the chance to help people with their vision. You will play a big part in making a difference in the lives of patients and be part of a company with a clear purpose, cutting-edge innovation and breakthrough technology in eye-care.
- Work Flexibility: Requirement to be on-site in Erlangen 3 days per week, the other 2 days per week employees can work from home. No other travel requirements.