Regulatory Affairs Specialist - Johnson & Johnson MedTech

J&J Family of Companies; Wokingham; Hybrid; GBP 40,000 - 70,000

Job description

J&J Family of Companies Regulatory Affairs Specialist - Johnson & Johnson MedTech in Wokingham, United Kingdom

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 www.jnj.com

Job Function: Regulatory Affairs Group

Job Sub Function: Regulatory Affairs

Job Category: Professional

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 will involve monitoring the Regulatory Environment and ensuring local regulatory compliance of products and innovation of processes.

Key Responsibilities:

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

What you will be doing:

1. Ensuring that the company's products comply with relevant legislation and standards to be placed on the market in the UK/IRE.
2. Monitoring local Regulatory Environment international legislation, guidelines, and customer practices.
3. Ensuring organization 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 on products, business/licenses, and patients/HCP.
6. Preparing submissions and registering Medical Devices with MHRA.
7. Reviewing company practices, work processes, or operational plans and scheduling - feeding back opportunities for change/improvement.
8. Supporting business with copy review of assets.
9. Supporting requests from commercial and other functional teams to assist with regulatory documentation for customers.

What you will bring:

• Degree in Science, Law is preferred.

Knowledge of:

• UK Regulation.
• MDD Directive & MDR Regulation in EU and UK.
• Very comfortable working with databases, and advanced Excel skills.
• Working knowledge of medical devices regulatory documentation.
• Awareness or experience as UKRP would be a plus.

Preferred:

• Comfortable working on multiple tasks simultaneously and executing them effectively.
• Project management experience.
• Experience of supporting tenders.
• High degree of initiative.
• Outstanding collaboration to cultivate the strength of a network.
• Communication and negotiation skills.
• Open-minded, listens to others.
• Able to handle complex organizational structures.
• At ease in an international environment.
• Diplomacy.

Other required:

• Fluent in English.
• Preferred hybrid working pattern with an office location in Wokingham, moving to Maidenhead in 2026, in the United Kingdom or the Dublin office in Ireland.
• If based in the UK, monthly attendance to the UK Wokingham office for team face-to-face connections.
• Further potential to consider remote location within the UK or IRE, with monthly attendance to the UK office for the right candidate.
• Responsible for primarily supporting the Johnson & Johnson MedTech business unit.