27 days ago
Hamlyn Williams has partnered with a well known global medical technoloy comapny based in the Berlin area that is in a Major phase of growth and looking for a Senior Quality/ Regulatory Manager for a duration of 3-6 months
The role will involve:
- This position will involve acting as the Quality Management Representative and Person Responsible for Regulatory Compliance.
- For this position you will be managing the internal audit program
- Manage GMP and other quality system trainings
- You will be developing and implementing global regulatory strategies. You will also be overseeing all aspects of regulatory submission development, and interface with health authorities.
- Lead discussions with regulatory agencies (FDA, Notified Bodies etc.) to ensure approval of regulatory submissions.
For this role you will need:
- Experience in the medica technology space specifically with saMD
- Experience with both Quality Assurance and Regulatory Affairs
- Fluent english ,german language is desireable
I am a Quality Assurance and Regulatory Affairs market specialist working with a large variety of clients across the Medical Device industries. If this role is of interest to you, or if you’d like to explore other opportunities in the market, please feel free to reach out directly. Contact Leah at +44 020 3545 1118 or at firstname.lastname@example.org.