Regulatory Affairs Specialist - Johnson & Johnson MedTech
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 personalized. Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver 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 process innovations.
Key Responsibilities
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, licenses, and their impact on HCPs and patients. Ensuring company compliance in all Regulatory activities.
What You Will Be Doing
1. Ensuring product compliance with relevant legislation and standards for the UK/IRE market.
2. Monitoring local and international regulatory environments, legislation, guidelines, and practices.
3. Ensuring organizational compliance with all applicable regulations and J&J policies.
4. Keeping updated with the company's product range.
5. Performing impact assessments of regulatory changes on products, licenses, and patients/HCPs.
6. Registering Medical Devices with MHRA.
7. Reviewing company practices, workflows, and operational plans, providing feedback for improvements.
8. Supporting business teams with regulatory documentation and asset review.
What You Will Bring
1. A degree in Science or Law preferred; Medical device background is advantageous.
Knowledge Of
1. UK Regulation
2. MDD Directive & MDR Regulation in EU and UK
3. Device changes including ‘significant change’ management
4. Working with databases and advanced Excel skills
5. Medical device regulatory documentation
6. UK Responsible Person (UKRP) knowledge is a plus
Preferred Skills
1. Ability to handle multiple tasks effectively
2. Experience supporting Tenders
3. High initiative and collaborative mindset
4. Strong communication and negotiation skills
5. Open-minded and customer-focused
6. Ability to navigate complex organizations and international environments
7. Organized with attention to detail
8. Diplomacy skills
Other Requirements
1. Fluent in English
2. Willingness to travel approximately 10%
3. Hybrid working pattern preferred, with office locations in Wokingham, Maidenhead, or Dublin. Remote options within the UK or Ireland considered with monthly office attendance.
4. Primarily supporting Johnson & Johnson MedTech business unit.
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