Regulatory Affairs Specialist

The Company

Our client is a market leader in the manufacturing and distribution of medical devices due to growth they now require a Regulatory Affairs Specialist.

The Role

• The role is to support the company by ensuring they remain compliant with local and international regulations-UK Conformity Assessed (UKCA) Medical Device Regulations (MDR).
• Management of the online MHRA Portal to register medical devices for the UK and IE.
• MHRA Portal data maintenance to ensure accuracy and precision.
• MHRA Portal - Management of 'Letters of Designation’ for varying manufacturing sites.
• Collaboration with other sites to ensure technical documentation availability and accuracy for the registration of medical devices.
• Management of the 2028 transition of all products from CE to UKCA marking from a distributor perspective.
• Regulatory updates - To support the manufacturer when regulation changes could impact the UK and IE markets.
• Provide the necessary expertise and guidance to ensure continued supply of goods to market (Regulatory Affairs Requests).
• Clear understanding of GMDN / UDIDI Classifications
• To ensure all distributor responsibilities are completed and updated accordingly.
• Support the Purchasing Organisation with onboarding new suppliers.
• Collaborate with varying functions over multiple sites with regulatory queries to ensure compliance.

The Person

• University Graduate with a Science or Business degree (essential).
• Lean Six Sigma knowledge (desirable).
• Experience of working in a medical device regulatory role.
• Trained and competent in ISO 13485:2016. (essential)
• Demonstrate a clear understanding of MDR 2002 Regulations
• Excellent communication skills, written and verbal, with concise expression.
• Sound judgment: e.g. in analysing complex issues, evaluating the severity of consequences, setting priorities, choosing solutions, etc.
• Data driven.
• Proficient in Word, Excel (including graphs) and PowerPoint.
• Prepared to travel as required.

The Benefits

• You will be working for a well-established growing employer.
• An excellent salary.
• A company experiencing continued growth, expansion and investment.
• The company are fully compliant with the latest health and safety requirements for current safe working practices.