Your Responsibilities
* Your key responsibilities will include:
* Generating and maintaining technical documentation for compliance with applicable regulations
* Initiating change requests to update IFU and labelling of product portfolio
* Reviewing product and process change requests
* Supporting regulatory compliance projects as required, e.g., EU MDR and new product development/sustaining projects
* Driving process updates and contributing to process improvements
Your Qualifications
* University degree in a scientific subject, such as Biomedical Science, Pharmacy, Engineering, or a similar discipline
* Demonstrable experience in regulatory affairs, quality assurance, or R&D in the medical device industry
* A good understanding of the regulatory framework applicable to medical devices
Your Competencies
* Patient Focus - We put patients at the heart of everything
* Integrity - We do the right thing
* Innovation - We look for new ways to make things better
* Impact - We take accountability and get things done
* Empathy - We care for one another and work together
Your Benefits
* In addition to a competitive salary, you will receive a generous annual leave entitlement
* Eligibility for private medical cover
* Comprehensive company pension scheme
* Private medical and dental cover
* Annual health check with BUPA, funded by us
* Employee Assistance Program to support health, mental, and emotional wellbeing
* Subsidised staff restaurant and free parking at our HQ
* Other benefits include discounted gym and wellness memberships, cashback, and discounts with major UK retailers
Further Information
Valuing diverse perspectives and lifestyles is closely aligned with our core values. We encourage all candidates to apply regardless of gender, nationality, ethnicity, religion, age, disability, sexual orientation, marital status, or other conditions and restrictions that cannot be shown.
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