Regulatory Affairs Specialist - Johnson & Johnson MedTech

Jnjmedtech; Wokingham; Hybrid; GBP 35,000 - 55,000; Full time

Job summary

A leading company in healthcare innovation is looking for a Regulatory Affairs Specialist in Wokingham. The role involves ensuring compliance with UK regulations, monitoring the regulatory environment, and supporting business teams with documentation. Candidates should have a degree in Science or Law and strong communication skills. A hybrid working pattern is preferred, with some travel expected.

Qualifications

• Degree in Science or Law preferred; Medical device background is advantageous.
• Fluent in English.
• Knowledge of UK Regulation and Medical device regulatory documentation.

Responsibilities

• Monitor and execute local regulatory requirements.
• Ensure compliance with relevant legislation and standards.
• Perform impact assessments of regulatory changes.

Skills

Regulatory compliance

Communication

Negotiation

Attention to detail

Organizational skills

Education

Degree in Science or Law

Tools

Advanced Excel

Job description

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.