Regulatory Affairs Specialist (mfd) Fixed Term Employee ( to )

Stellenbeschreibung:

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 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 more at.

About J&J Vision: Fueled by innovation at the intersection of biology and technology, we are developing the next generation of smarter, less invasive, more personalized treatments. Are you passionate about improving and expanding on the possibilities of vision treatments? Join a team reimagining how vision is improved. Our Vision team solves the toughest health challenges. Help combine cutting‑edge insights, science, technology, and people to encourage eye‑care professionals and patients to proactively protect, correct and enhance healthy sight for life. Our products and services address these needs from pediatric to aging eye in a patient’s lifetime.

We are searching for a Regulatory Affairs Specialist – Fixed Term Employee (01/01/2026 to 31/12/2026).

Responsibilities

Lead and complete regulatory submissions and documentation for the EMEA region with primary responsibility for France and Switzerland.
Represent Vision Care products in interactions with national competent authorities (e.g. ANSM) and coordinate responses to authority questions.
Define and implement local regulatory strategies and identify the most appropriate regulatory pathways to enable market access or maintain business continuity aligned with Business Unit objectives.
Identify, quantify and communicate regulatory risks and recommend mitigations to cross‑functional partners (commercial, quality, supply chain, R&D).
Support international registrations, product release activities and updates to regulatory databases and records.
Provide regulatory input across the product lifecycle for changes impacting EMEA registrations: strategy, timelines, change control and submission documentation.
Analyze and interpret regulatory requirements, changes and trends (especially in France and Switzerland) and advise partners on implications and required actions.
Review and approve promotional materials, labeling, packaging and instructions for use for assigned products to ensure compliance with applicable regulations.
Conduct regulatory impact assessments for product changes and prepare submission of required updates to Competent Authorities.
Support internal and external partner interactions to ensure uninterrupted product supply.

Qualifications

Degree in life sciences, pharmacy, regulatory affairs or equivalent.
Minimum 2 years of experience in regulatory affairs (medical device or pharmaceutical/OTC experience desirable) including hands‑on experience with EMEA registrations.
Knowledge of EU regulatory frameworks including centralised and decentralised procedures, clinical trial regulations and post‑approval lifecycle management.
Experience with regulatory authorities in France; experience interacting with ANSM preferred.
Excellent written and verbal communication skills in French and English.
Project‑management skills with experience coordinating cross‑functional initiatives.
Excellent communication and stakeholder‑management abilities; strong teammate.
Proven ability to develop regulatory strategy, manage submissions and lead cross‑functional projects.
Strong analytical skills, attention to detail and ability to identify and manage regulatory risk.
Demonstrated ability to manage multiple projects simultaneously.