My client, a global Medical Device manufacturer are looking for RA Team Lead to join their growing team. This individual will work closely with the Head of QA/RA to ensure that the RA team’s work is done to a high standard. The site offers a fast paced and family-oriented environment with a product portfolio that's consistently updated making the Regulatory department an exciting place to work.
- You will oversee and coordinate international approvals and re-registrations, from developing the approval strategy to documentation.
- You lead the regulatory affairs team (5 employees) within the business unit, paying special attention to the strategic development of the team and the design of efficient processes and methods.
- You are a competent advisor on regulatory issues within the business unit and for our international subsidiaries, with a clear focus on our growth targets.
- You are an active partner in contact with domestic and foreign authorities.
- Completed degree with a technical or scientific focus.
- Several years of professional and first management experience in a comparable position with an international focus
- Current know-how of common approval requirements, questions of product liability and medical technology standards, e. B. ISO 13485, ISO 14971, 21 CFR part 820, MPG, MDR
- Very good MS Office and SAP as well as business fluent English and German skills
We aim to be an equal opportunity recruiter and we are determined to ensure that no applicant receives less favourable treatment on the grounds of gender, age, disability, religion, belief, sexual orientation, marital status, or race, or is disadvantaged by conditions or requirements.
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