Senior Regulatory Affairs Specialist - Submissions Lead

Medtronic Europe Sàrl; Tolochenaz; On-site; CHF 120,000 - 160,000; Full time

Job summary

Medtronic Europe Sàrl in Tolochenaz (VD) seeks a Senior Regulatory Affairs Specialist for a 100% permanent role. You will coordinate regulatory submissions, renewals, and inspections, and advise on labeling, manufacturing, and clinical protocol changes to ensure compliance.

Immediate start and strong cross‑functional collaboration required. The role emphasizes tracking systems, regulatory strategy, and interactions with authorities, with a focus on timely approvals and maintaining high quality

Qualifications

• Bachelor's degree in a relevant field.
• More than 3 years regulatory affairs experience.
• Fluent in French, Swiss German, Italian, and English.

Responsibilities

• Directs or coordinates regulatory submissions from all areas.
• Leads license renewals and annual registrations.
• Recommends changes for labeling, manufacturing and clinical protocols for compliance.
• Direct interaction with regulatory agencies as needed.

Skills

Regulatory affairs

Documentation coordination

Clinical trial submissions

Regulatory inspections

Education

Bachelor’s degree or equivalent

Job description

Medtronic Europe Sàrl in Tolochenaz (VD) seeks a Senior Regulatory Affairs Specialist for a 100% permanent role. You will coordinate regulatory submissions, renewals, and inspections, and advise on labeling, manufacturing, and clinical protocol changes to ensure compliance.

Immediate start and strong cross‑functional collaboration required. The role emphasizes tracking systems, regulatory strategy, and interactions with authorities, with a focus on timely approvals and maintaining high quality