Regulatory Partner Medical Devices
2 weeks ago
Company:
Our client is one of the world's premier innovative biopharmaceutical companies, discovering, developing and providing over 160 different medicines, vaccines and consumer healthcare products to help improve the lives of millions of people in the UK and around the world every year.
Location:
This role is based at our clients site in Welwyn Garden City.
Regulatory Partner Medical Devices Role:
- Support the team in ensuring that regulatory requirements are met for Clinical Trial Applications that involve Medical Devices of any nature (e.g. physical devices, digital devices, in-vitro diagnostics, etc).
- Continuously monitor the changes to the UK Regulatory environment and provide an impact assessment on changes to the current framework and/or implementation of new Regulations and gather regulatory intelligence.
- Provide support for the implementation/adaptation of the medical device structure across the UK Affiliate.
- Provide regulatory advice to project teams to ensure continued regulatory compliance and timely market release.
- Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance.
- Advise the manufacturers/global team to obtain and maintain a UKCA mark and/or any relevant regulatory milestone that concern the UK.
- Support the teams in any interaction with the MHRA that concerns medical devices.
- Provide regulatory expertise on new product development.
- Support the maintenance of regulatory files and tracking databases to ensure prompt and accurate access to company regulatory information.
Your Background:
- Educated to degree level or above in life sciences or a related field.
- A strong Regulatory Affairs background in the Medical Device field and the ability solve complex regulatory issues that impact the chapter and/or wider business.
- Experience of the UK Market and working with the MHRA.
- Excellent communication, relationship building and negotiation skills.
Apply:
It is essential that applicants hold entitlement to work in the UK. Please quote job reference in all correspondence.
Please note:
This role may be subject to a satisfactory basic Disclosure and Barring Service (DBS) check.
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