Regulatory Affairs Specialist - Johnson & Johnson MedTech

Johnson & Johnson; Wokingham; Hybrid; GBP 40,000 - 55,000; Full time

Job summary

A leading company is seeking a Regulatory Affairs Specialist to ensure compliance with local regulations in the UK and Ireland. The role involves monitoring the regulatory environment, ensuring product compliance, and supporting business operations in a hybrid working model. Ideal candidates will have a degree in Science or Law, strong communication skills, and the ability to navigate complex organizational structures.

Qualifications

• Degree in Science or Law preferred; Medical device background advantageous.
• Fluent in English; willing to travel approximately 10%.

Responsibilities

• Monitor and execute local regulatory requirements.
• Ensure product compliance with relevant legislation for the UK/IRE market.
• Register Medical Devices with MHRA.

Skills

Communication

Negotiation

Attention to detail

Collaboration

Education

Degree in Science

Law preferred

Tools

Advanced Excel

Job description

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.

1. Monitor and execute according to local regulatory requirements, advising appropriate partners.
2. Ensure J&J standard requirements and project timelines are met.
3. Apply regulatory requirements to RA strategies and impact assessments, considering changes to products, business models, and licenses, with regard to impact on HCPs and patients. Ensure company compliance in all Regulatory activities.

What you will be doing:

1. Ensure product compliance with relevant legislation and standards for the UK/IRE market.
2. Monitor local regulatory environment, international legislation, guidelines, and customer practices.
3. Ensure organizational compliance with all applicable regulations and J&J policies.
4. Stay updated with the company's product range.
5. Perform impact assessments of regulatory changes on products, licenses, and patients/HCPs.
6. Register Medical Devices with MHRA.
7. Review company practices, work processes, or operational plans, and provide feedback for improvements.
8. Support business with review of regulatory assets and documentation.
9. Assist with regulatory documentation requests from commercial and other teams.

What you will bring:

• Degree in Science, Law preferred; Medical device background advantageous.

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
• Medical device regulatory documentation
• UKRP experience is a plus

Preferred:

• Ability to multitask effectively
• Experience supporting Tenders
• High initiative and collaboration skills
• Strong communication and negotiation skills
• Open-mindedness and customer focus
• Ability to navigate complex organizational structures
• Comfort in an international environment
• Attention to detail and organization skills
• Diplomacy

Other requirements:

• Fluent in English
• Willing to travel approximately 10%
• Hybrid working pattern preferred, with office locations in Wokingham (moving to Maidenhead in 2026), Ireland (Dublin), or remote within the UK/IRE with monthly office attendance.
• Support primarily the Johnson & Johnson MedTech business unit.