Regulatory Affairs Manager (m/f/d) | Medical Devices | Frankfurt
In this position you will be mainly responsible for managing regulatory aspects of medical devices, focusing on compliance, regulations and published guidance documents. Furthermore, you will coordinate and manage translations and approvals by local regulatory experts and work as part of projects teams in order to create launch materials for new products and indications.
What are your tasks as "Regulatory Affairs Manager (m/f/x)"?
- Preparing and submitting applications for new approvals/registrations and answering questions in a timely and accurate manner
- Ensure high quality of dossiers for the submission of applications: updating dossiers and advising the development departments as analytical methods, preclinical and clinical development
- Participate in scientific advisory meetings with regulatory authorities
- Conduct product maintenance by taking care of the Life-Cycle Management worldwide
- Coordinate the development of regulatory strategies, work in project teams and are the contact person for regulatory requirements
What does the position offer to you?
- Exciting projects & personal development
- Flexible work hours
- Pension plan and childcare
- 30 vacation days & 6 additional compensation days
What requirements do you need for "Regulatory Affairs Manager (m/f/x)"?
- Bachelor's degree in scientific or health discipline, preferably M.S. or higher
- At least 2 years of pharmaceutical/medical technology industry experience and a minimum of 1 years as a regulatory affairs reviewer of labelling materials
- Strong knowledge of EU and ROW regulations and guidance pertaining to medical device
- Excellent organisational, prioritisation and planning skills
- Excellent language skills in German and English (written and spoken), Arabic or Russian are a plus
About the client?
Our client an independent, family-owned company, and a market leader across multiple therapeutic areas. Based on over 110 years of experience, they are a global leader in therapeutic innovations that empower patients to live fully and achieve their individual goals.
Are you interested in such company? Then you should apply now! If you would like to receive Information, I would be happy to let you more about it and other opportunities:
Contact for application:
- E-Mail: firstname.lastname@example.org
- Tel: +49 (0)89 / 26200311