Regulatory Affairs Specialist - Johnson & Johnson MedTech

Johnson & Johnson; Wokingham; Hybrid; GBP 35,000 - 55,000

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

• Key Responsibilities include monitoring of and execution according to local regulatory requirements and advising appropriate partners.
• Ensuring J&J standard requirements and project timelines are met.
• Follows regulatory requirements and applies them to RA strategies and impact assessments, on changes to products, business models, licences considering impact to HCPs and patients. Ensuring company compliance in all activities related to Regulatory input.

What you will be doing:

• Ensuring that the company's products comply with relevant legislation and standards to be placed on the market in the UK/IRE
• Monitoring local Regulatory Environment international legislation, guidelines and customer practices.
• Ensuring organization compliance with all applicable regulations and J&J policies.
• Keeping up to date with a company's product range
• Performing Impact assessments of regulatory changes on products, business/licenses and patients/HCP.
• Preparing submissions and registering Medical Devices with MHRA
• Reviewing company practices work processes or operational plans and schedule - feeding back opportunities for change/ improvement
• Supporting business with copy review of assets
• 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
• Environmental Directives
• Very comfortable working with databases, and advanced xls 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
• Customer focused
• Able to handle complex organization structures
• At ease in an International environment.
• Well organized, sense for detail
• Diplomacy

Other required:

• Fluent in English
• 10% Travel
• 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 F2F 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