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Job Description:

Johnson & Johnson Medtech | Orthopaedics is recruiting for a Regulatory Affairs Specialist, to join its UK/IRE team, based in the Leeds office.

Johnson & Johnson announced plans to separate our Orthopaedics business to establish a standalone orthopaedics company, operating as DePuy Synthes. The process of the planned separation is anticipated to be completed within 18 to 24 months, subject to legal requirements, including consultation with works councils and other employee representative bodies, as may be required, regulatory approvals and other customary conditions and approvals.

Should you accept this position, it is anticipated that, following conclusion of the transaction, you would be an employee of DePuy Synthes and your employment would be governed by DePuy Synthes employment processes, programs, policies, and benefit plans. In that case, details of any planned changes would be provided to you by DePuy Synthes at an appropriate time and subject to any necessary consultation processes. 

Purpose of the role:

This role will involve monitoring of the UK/IRE 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 applying 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:

• Registering Medical Devices with MHRA

• Performing UK/IRL impact assessments of regulatory changes on products, business/licenses and patients/HCP.

• Managing internal database updates for products destined for UK and IRL markets

• Supporting requests from commercial and other functional teams to assist with regulatory documentation for customers

• Supporting business with copy review of assets

• Ensuring that the company's products comply with relevant legislation and standards to be placed on the market in the UK/IRE

• Ensuring organization compliance with all applicable regulations and J&J policies.

• Keeping up to date with a company's product range

• Reviewing company practices work processes or operational plans and schedule -feeding back opportunities for change/ improvement

What you will bring:

• Degree in Science, Law is preferred and/or:

• Medical device background

Knowledge of:

• UK Regulation

• MDD Directive & MDR Regulation in EU and UK

• Changes to devices including 'significant change' 

• 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

• Knowledge of MHRA DORS portal

• 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

• Hybrid working pattern (3 days in office, 2 days remote) with an office location in Leeds, United Kingdom

• Some travel to Wokingham office anticipated in the beginning to familiarise yourself with existing team and support training.

• Responsible for primarily supporting the Johnson & Johnson MedTech | Orthopaedics business unit

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