Posted in: Other in Leeds | Posted: |
A fantastic opportunity is available for a Regulatory Affairs Associate to join a thriving and expanding medical device company based in West Yorkshire.
The main responsibility of this role swill be to ensure that the regulatory requirements of the company are met in line with project deadlines.
Duties and Responsibilities
- Update and Maintain Technical files
- Oversee and assist with global product registrations in accordance with country-specific requirements and internal systems
- Determine regulatory pathways for product registration in various global countries
- Perform medical device regulatory compliance gap analyses and implementation.
- Perform distributor evaluation and approval.
- Provide Regulatory input on project teams for projects including but not limited to new product development, continuous improvement, regulatory compliance.
The Candidate
The ideal candidate for this role will have a proven track record within the Medical Device sector.
In depth knowledge of ISO 13485
Knowledge/understanding of EU Medical Device Regulations (MDR) and MDSAP regulations
BSc (or equivalent) in a Life Science or related field.
Excellent opportunities to develop are available as our client enters a period of growth. Please apply now