Regulatory Affairs Specialist - Johnson & Johnson MedTech

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

Job summary

A leading healthcare company is seeking a Regulatory Affairs Specialist to ensure compliance with local regulations in the UK and Ireland. This role involves monitoring regulatory environments, supporting documentation, and collaborating with various teams. The ideal candidate will have a degree in Science or Law and experience in medical devices. The position offers a hybrid working pattern with potential for remote work.

Qualifications

• Degree in Science or Law preferred.
• Medical device background required.

Responsibilities

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

Skills

Communication

Negotiation

Multitasking

Attention to Detail

Education

Degree in Science

Degree in Law

Tools

Advanced Excel

Databases

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.

Key Responsibilities include:

1. Monitoring and executing according to local regulatory requirements and advising appropriate partners.
2. Ensuring J&J standard requirements and project timelines are met.
3. Applying regulatory requirements to RA strategies and impact assessments, considering changes to products, business models, licences, and their impact on HCPs and patients.
4. Ensuring company compliance in all activities related to Regulatory input.

What you will be doing:

1. Ensuring product compliance with relevant legislation and standards for the UK/IRE market.
2. Monitoring local Regulatory Environment, international legislation, guidelines, and customer practices.
3. Ensuring organizational compliance with all applicable regulations and J&J policies.
4. Keeping up to date with the company's product range.
5. Performing impact assessments of regulatory changes.
6. Registering Medical Devices with MHRA.
7. Reviewing company practices, work processes, or operational plans for improvements.
8. Supporting business with regulatory documentation and asset review.
9. Assisting commercial and other teams with regulatory documentation for customers.

What you will bring:

1. Degree in Science, Law preferred.
2. Medical device background.

Knowledge of:

1. UK Regulation
2. MDD Directive & MDR Regulation in EU and UK
3. Device changes including 'significant change'
4. Working with databases and advanced Excel skills
5. Medical devices regulatory documentation
6. UKRP experience is a plus

Preferred qualities:

1. Ability to multitask effectively.
2. Experience supporting Tenders.
3. High initiative and collaboration skills.
4. Strong communication and negotiation skills.
5. Open-mindedness and customer focus.
6. Ability to handle complex organizational structures.
7. Comfort in an international environment.
8. Well-organized with attention to detail.
9. Diplomacy skills.

Other requirements:

1. Fluent in English.
2. Willingness to travel approximately 10%.
3. Hybrid working pattern preferred, with an office in Wokingham (moving to Maidenhead in 2026) or Dublin, Ireland.
4. Potential for remote work within the UK or IRE with monthly office attendance.
5. Primary support for Johnson & Johnson MedTech business unit.