Regulatory Affairs Leader
À propos de nous
ENOVIS™
Enovis Corporation (NYSE : ENOV) est une entreprise de technologie médicale en forte croissance, centrée sur l'innovation et engagée dans le développement de solutions cliniquement différenciées, visant à améliorer concrètement les résultats pour les patients et à transformer les processus de soins. Portée par une culture d'amélioration continue, des talents internationaux et un esprit d'innovation, Enovis propose une large gamme de produits, services et technologies intégrées, favorisant un mode de vie actif dans le domaine de l'orthopédie et au-delà.
Pour en savoir plus, visitez : www.enovis.com
Who We Are
ABOUT ENOVIS™
Enovis Corporation (NYSE: ENOV) is an innovation-driven medical technology growth company dedicated to developing clinically differentiated solutions that generate measurably better patient outcomes and transform workflows. Powered by a culture of continuous improvement, global talent and innovation, the Company's extensive range of products, services and integrated technologies fuels active lifestyles in orthopedics and beyond. For more information about Enovis, please visit www.enovis.com.
Quelles seront tes responsabilités ? | What you'll do ?
Job Title:
Regulatory Affairs Leader
Reports To:
Regulatory Affairs Manager
Location:
Rennes, France
Job Title/High-Level Position Summary:
The Regulatory Affairs Leader is responsible for ensuring regulatory compliance across Enovis F&A medical device activities throughout the product lifecycle, including market entry, maintenance, and post-market surveillance. The role acts as a key interface for strategic projects between internal teams, external partners, and regulatory authorities.
Key Responsibilities:
Regulatory Compliance & Documentation
- Ensure technical documentation is complete, maintained, and compliant with applicable regulatory requirements and standards
- Ensure ongoing compliance once Enovis F&A devices are placed on the market
- Validate regulatory content in technical files, IFUs, labeling, and marketing materials
- Coordinate and contribute to product risk management activities (ISO 14971)
- Maintain consistency, integrity, and updates of technical dossiers
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Regulatory Strategy & Submissions
- Define and implement regulatory registration strategies
- Ensure integration of export requirements (legalization, registrations, etc.)
- Manage regulatory submissions and renewals (CE marking, 510(k), export certifications, etc.)
- Ensure compliance with market authorization requirements and lifecycle management
- Submit required periodic reports to competent authorities
V&V Activities
- Conduct regulatory impact assessments for product, process, and system changes
- Ensure implementation of required regulatory actions following gap analyses
- Contribute to post-market surveillance activities (PMS, PSUR, PMSR)
- Maintain regulatory data in internal and external databases
- Manage regulatory aspects of product availability (ERP "blocking/unblocking")
Stakeholder & External Communication
- Act as regulatory contact for customers, distributors, notified bodies, suppliers, and internal teams
- Manage communication with competent authorities regarding regulatory matters
- Support and manage regulatory aspects of distributor quality agreements
- Inform internal and external stakeholders of regulatory changes
Quality System & Audits
- Participate in notified body and regulatory audits
- Manage regulatory requirements within ISO 13485 QMS and 21 CFR Part 820 frameworks
- Support product release activities, including batch dossier approval
Qualifications:
- At least 5 years of professional experience in regulatory affairs related to medical devices.
- Management of a strategic project involving multiple departments within the company.
- Proficiency in European medical device regulations (ideally 2017/745),
- Knowledge of CE marking procedures and FDA submission processes,
- Participation in Quality Management System audit (ISO, MDSAP, FDA inspection, etc.),
- Ability to incorporate requirements related to export registrations, document legalization, etc.,
- Knowledge of ISO 14971
- Ability to manage cross-functional projects
- Proficiency in technical English
- Proficiency in office software (Word, Excel) is required.
- Organization and autonomy
- Strong organizational skills with attention to detail and accuracy
- Ability to work independently and manage priorities effectively
- Strong communication and writing skills
Déclaration sur l'égalité des chances
En conformité avec la législation française, Chez Enovis, nous nous engageons à offrir des chances égales à tous en matière d'emploi. Les décisions relatives à l'emploi sont fondées uniquement sur le mérite, les qualifications et les besoins de l'entreprise. Nous appliquons une politique d'égalité de traitement pour tous les employés et candidats, sans discrimination fondée sur la race, la couleur, la religion, l'origine nationale, le sexe, l'orientation sexuelle, l'identité sexuelle, l'âge, le statut d'ancien combattant, le handicap ou toute autre caractéristique sans rapport avec les qualifications ou les performances professionnelles d'une personne. Cet engagement s'étend à tous les aspects de l'emploi, y compris le recrutement, l'embauche, l'affectation des tâches, la rémunération, la formation, la promotion, la rétrogradation, les mutations, les licenciements, les mesures disciplinaires et le départ, ainsi que toutes les autres conditions d'emploi.
Equal Employment Opportunity
At Enovis, we are committed to providing equal employment opportunities to all individuals. Employment decisions are based solely on merit, qualifications, and the needs of the business. We uphold a policy of equal treatment for all employees and applicants, without discrimination based on race, color, religion, national origin, sex, sexual orientation, gender identity, age, veteran status, disability, or any other characteristics unrelated to a person's qualifications or job performance. This commitment extends to all aspects of employment, including recruitment, hiring, job assignments, compensation, training, promotion, demotion, transfers, layoffs, discipline, and separation, as well as all other terms and conditions of employment.
Perks and Benefits
Health and Wellness
- Health Insurance
- Dental Insurance
- Vision Insurance
- HSA With Employer Contribution
- Mental Health Benefits
Parental Benefits
- Birth Parent or Maternity Leave
- Adoption Assistance Program
Work Flexibility
- Hybrid Work Opportunities
Office Life and Perks
Vacation and Time Off
- Paid Vacation
- Paid Holidays
- Personal/Sick Days
- Volunteer Time Off
Financial and Retirement
- 401(K) With Company Matching
- Stock Purchase Program
- Performance Bonus
Professional Development
- Tuition Reimbursement
- Promote From Within
- Leadership Training Program
- Access to Online Courses
- Lunch and Learns
Diversity and Inclusion
- Unconscious Bias Training
- Employee Resource Groups (ERG)