Sr Specialist Post Market Surveillance, EMEA

Integra-Lifesciences; Saint-Priest; Sur place; EUR 60 000 - 90 000; Plein temps

Résumé du poste

Integra Lifesciences in France is seeking a Regulatory Vigilance Specialist to support post‑market compliance and medical device vigilance, assessing patient and compliance risk and coordinating with regulatory authorities.

The role requires a Bachelor’s degree in science, 3–5 years’ experience in the medical device sector, knowledge of ISO13485/MDR, and strong writing, project management, and cross‑functional collaboration skills.

Qualifications

• Bachelor’s degree in science or related field.
• 3–5 years in medical device/pharma with quality engineering/regulatory focus.
• Knowledge of ISO13485, MDR, and adverse event reporting considered a plus.
• Proficient with Excel/SharePoint and web navigation.

Responsabilités

• Evaluate complaints and determine reportability under European regulation.
• Complete decision trees with cross‑department input.
• Prepare Manufacture Incident Reports for vigilance and submit to authorities.
• Prepare authorities inquiries with site support and timely submission.
• Support European Medical Specialists in vigilance decisions or reporting.
• Participate in regulatory audits/inspections as required.
• Represent Integra in PMS working groups.
• Transfer information to stakeholders and update procedures as needed.
• Stay updated on new regulations, standards, and guidance documents.

Connaissances

Regulatory affairs concepts

Medical device knowledge

Quality systems

Risk assessment

Regulatory writing

Formation

Bachelor's degree in science

Outils

Excel

SharePoint

Description du poste

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what’s possible and making headway to help improve outcomes.

The position supports the effective implementation of Integra's Post Market Compliance systems including Medical Device Vigilance Reporting processes based on international requirements. The position requires participation in and at times lead activities that identify, assess and determine the level of patient and/or compliance risk associated with Integra products in the marketplace.

RESPONSIBILITIES

• Evaluate complaints recorded in the complaint database by Complaint department and decide if recorded events are reportable according to European regulation.
• Complete the decision tree and justify the decision with the help of various departments and manufacturing sites if needed.
• Prepare Manufacture Incident Report for medical device vigilance and submit to regulatory authorities.
• Prepare Authorities Inquiry response with manufacturing site support when needed and submit to regulatory authorities on time.
• Support other European Medical Specialists in vigilance decision or reporting if needed.
• Provide support and/or participate in regulatory audits/inspections as required.
• Represent Integra in MEDTECH and SNITEM PMS working group.
• Participate in meetings and transfer information to Integra Stakeholders.
• Write and or revise department procedures as needed.
• Keep apprised of new regulations standards, policies, and guidance documents issued by relevant regulatory authorities that may impact vigilance.
• Perform all other related duties as directed by management.

QUALIFICATIONS

• Bachelor's degree in science or other technically related field, or equivalent work experience.
• 3-5 years’ experience in a medical device or pharmaceutical company responsible for administration of quality engineering activities specifically those related to the assessment of risk and recalls, preferred Knowledge on ISO13485, applicable MEDDEVs, MDR... ASQ Quality Engineer and/ or Regulatory Affairs Certified (CE/ RAC) preferred.
• Computer skills to include knowledge and proficiency with Excel, Sharepoint and proficient use of the worldwide web network.
• Strong writing, project management, problem solving, and communication skills.

Whatever your specialty, you’ll find an ideal setting for building a rewarding career. Along the way, you’ll have the satisfaction of knowing your work matters, that it’s making patients’ lives better, making a positive and lasting difference. You’ll find that the pace is exhilarating – because the need is so urgent. You’ll be challenged – and supported – by the most dynamic and inspiring people in your profession. And you’ll grow a career that is more impactful and fulfilling then you thought possible. More than 4,200 Integra employees already know we’re a great place to build a career. Here’s your chance to discover that for yourself.