Regulatory Affairs Project Manager

Location: Pinewood Campus, Wokingham

Working mode: Hybrid, 3 days on-site and 2WFH

Duration: Contract running until the end of 2025 (opportunity for a contract extension)

Hours: Full-time, 37.5 hours per week

Pay rate range: Competitive hourly rate (PAYE and Umbrella options available, this role is inside IR35)

Johnson & Johnson Medical Ltd is recruiting for a Regulatory Affairs Contractor, located in the United Kingdom, to be part of the team in this dynamic dual legislative environment.

This role will involve monitoring of the Regulatory Environment in the UK and performing legislation interpretations, assisting with gap analysis in conjunction with the Quality group on the amended UK Medical Device Regulation S.I.618 and fostering feedback to relevant partners, and identifying activities to ensure local regulatory compliance.

Assisting with monitoring of the UK environment for future legislation, impact assessments for the UKCA program at JnJ.

roles and responsibilities

• Monitoring local Regulatory Environment for announcements, publications, and feed-back to high level relevant partners within 48hours.
• Primary responsible person for interpretating new regulatory requirements against the existing legislation and identifying the changes, determines internal strategies informing the Senior Manager Regulatory Affairs UK/IRE and the UKCA Program.
• Performs Impact assessments of regulatory changes on market access across all stakeholders & functions, not just Regulatory.
• Capable of articulating the interpretation of the legislation to senior management globally.

how to succeed

Required:

• UK Regulation (in-depth, understanding changes since the UK left the EU in detail)
• Interpretation of amended legislation and the context in which the changes impact the current UK legislation
• MDD Directive & MDR Regulation
• Impact assessments
• Gap analysis

Preferred:

Crucial Skills:

• Experience of sophisticated project management
• Experience of working with Notified Bodies/Approved Bodies
• Self starter due to previous experiences, requires little management direction.
• High degree of initiative.
• Outstanding collaboration to cultivate the strength of a network
• Communication and negotiation skills.
• Able to handle complexity of organization global structures
• At ease in an International environment.
• Well organized, sense for detail
• Diplomacy

Other:

• Fluent in English
• 10% Travel
• Hybrid working pattern with an office location in Wokingham, moving to Maidenhead in 2026, in the United Kingdom. Further potential to consider remote location within the UK, with monthly attendance to the UK office for the right candidate.

benefits

This role offers a very competitive hourly rate. This contract will run for until the end of 2025 and has a chance of extension.

you are welcome here

Johnson & Johnson is working to create an inclusive environment where diverse backgrounds, perspectives, and experiences are valued and each and every one of our people feels that they belong and can reach their potential. No matter who they are.

about Johnson & Johnson

Caring for the world, one person at a time has inspired and united the people of Johnson & Johnson for over 130 years. As a skilled contractor, you’ll play a key part in the thinking, strategy, dynamism - and impact - of this iconic global healthcare company as they touch the lives of nearly a billion people every day. Contribute to the next healthcare breakthrough with your next project at Johnson & Johnson.

application process

We are looking to process the first round of applications within the next 2 working days.

We do not accept applications via email. The pay rate for this role will depend on how you are paid. PAYE & Umbrella options are available.

Diversity, Equity & Inclusion

For more than 130 years, diversity, equity & inclusion (DEI) have been part of our cultural fabric at Johnson & Johnson and woven into how we do business every day. Our commitment to respect the dignity and diversity of all is embedded in our Credo.

We know that the success of our business depends on having the best talent in a workforce that reflects the diverse markets we serve around the world and an inclusive culture that values different perspectives and life experiences. That is why we are working to create an inclusive environment where diverse backgrounds, perspectives and experiences are valued and each one of our people feels that they belong and can reach their potential. No matter who they are. Diversity, Equity & Inclusion at Johnson & Johnson means “You Belong”.