Manager, EUDAMED &UDI

Poste

Temps plein

Permanent

Mid

Modalités

Zuchwil, Switzerland

Sur site

Exigences

6+ ans d'exp.

Bachelor

Permis UE/AELE

Langues

Anglais

Description

DePuy Synthes is recruiting for a Manager, EUDAMED &UDI located in Zuchwil, Switzerland. The Manager, EUDAMED & UDI, Regulatory is responsible for leading and coordinating regulatory activities related to EUDAMED and Unique Device Identification (UDI) compliance. This role plays a critical part in ensuring accurate , timely , and compliant regulatory data submissions in line with EU MDR requirements. The position partners closely with Regulatory Affairs, Quality, IT, and business stakeholders to support product lifecycle management, regulatory readiness, and sustained market access across Europe.

Responsabilités

Lead EUDAMED and UDI regulatory activities, ensuring compliance with EU MDR and related regulatory requirements.
Coordinate preparation, review, and submission of EUDAMED data, including actor, device, and vigilance‑related information.
Provide regulatory guidance and oversight for UDI implementation, maintenance, and data governance.
Partner with cross‑functional teams (Regulatory Affairs, Quality, IT, Supply Chain) to ensure data accuracy, consistency, and traceability.
Monitor changes to EU MDR, EUDAMED, and UDI requirements and assess impacts to products and processes.
Support internal and external audits, inspections, and regulatory assessments related to EUDAMED and UDI compliance.
Develop and maintain internal procedures, guidance, and training related to EUDAMED and UDI processes.
Drive continuous improvement initiatives to enhance regulatory data quality, efficiency, and compliance.

Exigences

Typically 6-8 years of progressive experience in Regulatory Affairs or regulatory data management within a regulated industry.
Strong knowledge of EU MDR, EUDAMED, and UDI regulatory requirements.
Experience coordinating regulatory data submissions and maintaining compliance records.
Ability to interpret regulatory requirements and translate them into operational processes.
Effective stakeholder management and communication skills.
Experience in the medical device or healthcare industry.
Exposure to regulatory inspections, audits, or notified body interactions.
Experience working in a global or matrixed organization.
Familiarity with regulatory information management systems (RIM).
Demonstrated experience driving regulatory process or data governance improvements.
Strong attention to detail and ability to manage complex data sets.

Avantages

For more information on how we support the whole health of our employees throughout their wellness, career and life journey, please visit www.careers.jnj.com.

Entreprise

Johnson & Johnson / Janssen

Healthcare

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 jnj.com . As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.