Regulatory Affairs Specialist - Johnson & Johnson MedTech

Johnson & Johnson MedTech; Wokingham; Hybrid; GBP 40,000 - 60,000; Full time

Job summary

A leading company in healthcare innovation seeks a Regulatory Affairs Specialist to ensure compliance with UK regulations and support product registrations. The role involves monitoring regulatory environments and collaborating with various teams to maintain standards. This position offers a hybrid work model, allowing flexibility while ensuring adherence to local requirements.

Qualifications

• Degree in Science or Law preferred, medical device background.
• Fluent in English.

Responsibilities

• Monitor and ensure compliance with local regulatory requirements.
• Perform impact assessments of regulatory changes on products.
• Register Medical Devices with MHRA.

Skills

Communication

Negotiation

Collaboration

Education

Degree in Science

Law Degree

Tools

Advanced Excel

Job description

Regulatory Affairs Specialist - Johnson & Johnson MedTech

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At Johnson & Johnson, we believe health is everything. Our strength in healthcare innovation empowers us to build a world where complex diseases are prevented, treated, and cured, where treatments are smarter and less invasive, and solutions are personal. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow and profoundly impact health for humanity. Learn more at https://www.jnj.com

Job Function

Regulatory Affairs Group

Job Sub Function

Regulatory Affairs

Job Category

Professional

All Job Posting Locations

Wokingham, Berkshire, United Kingdom

Job Description

Johnson & Johnson Medical Ltd is recruiting for a Regulatory Affairs Specialist, located in the United Kingdom or Republic of Ireland (UK/IRE), to be part of the team in this dynamic dual legislative environment.

Purpose Of The Role

This role involves monitoring the Regulatory Environment and ensuring local regulatory compliance of products and innovation of processes.

• Key responsibilities include monitoring and executing according to local regulatory requirements and advising appropriate partners.
• Ensuring J&J standard requirements and project timelines are met.
• Applying regulatory requirements to RA strategies and impact assessments, considering changes to products, business models, licenses, and their impact on HCPs and patients. Ensuring company compliance in all activities related to Regulatory input.

What You Will Be Doing

• Ensuring the company's products comply with relevant legislation and standards to be placed on the UK/IRE market.
• Monitoring local Regulatory Environment, international legislation, guidelines, and customer practices.
• Ensuring organization compliance with all applicable regulations and J&J policies.
• Keeping up to date with the company's product range.
• Performing impact assessments of regulatory changes on products, business/licenses, and patients/HCP.
• Registering Medical Devices with MHRA.
• Reviewing company practices, work processes, or operational plans and providing feedback for improvement.
• Supporting the business with copy review of assets.
• Assisting with regulatory documentation requests from commercial and other teams.

What You Will Bring

• A degree in Science, Law (preferred), and/or a medical device background.

Knowledge Of

• UK Regulation
• MDD Directive & MDR Regulation in EU and UK
• Device changes including ‘significant change’ processes, working with databases, and advanced Excel skills.
• Regulatory documentation for medical devices.
• UKRP awareness or experience (a plus).

Preferred Skills

• Ability to handle multiple tasks effectively.
• Experience supporting tenders.
• High initiative, collaboration, communication, and negotiation skills.
• Open-minded, customer-focused, well-organized, detail-oriented, diplomatic.
• Comfortable in an international environment.

Other Requirements

• Fluent in English.
• Willingness to travel 10%.
• Hybrid working pattern with office locations in Wokingham (moving to Maidenhead in 2026) or Dublin, Ireland. Remote options considered within the UK or Ireland with monthly office visits.
• Primarily supporting the Johnson & Johnson MedTech business unit.

Seniority level

Not Applicable

Employment type

Full-time

Job function

Legal

Industries

Hospitals and Health Care