Title: Head of Regulatory Affairs in Germany
Introductory Paragraph:
An exciting opportunity has arisen for a skilled and experienced individual to join our client's team as the Head of Regulatory Affairs. Our client is an innovative medical device company located in Germany who specialise in EPM technology. As their new hire, you will be responsible for providing regulatory guidance and subject matter expertise while ensuring compliance with local regulations.
Key Responsibilities:
Training & Guidance
- Oversee training on good regulatory practices to product development teams.
- Offer expert advice regarding emerging regulations that may impact the business.
- Ensure SOPs are adhered to by all members involved within the process.
Submission Management
- Respond promptly and accurately to requests from distributors or regulators regarding submissions renewals/new filings etc..
Documentation Control & Reviewing Changes
-Provide quality support staff with suitable guidelines when it comes down managing documents related towards local laws/regulations,
-Cross-check any proposed changes against existing design/labelling standards
Qualifications/Skills Required:
โ At least 4 years experience working directly within a similar role (dealing specifically with Medical Devices)
โ Strong leadership qualities; able to effectively manage/guide others inside your department/team
โ Excellent communication skills both verbally/written German fluency would be preferred but not essential
If this sounds like something you'd excel at please apply today!
