EU MDR Regulatory Lead — Class III Implant CE Mark

elemed; Zug; Hybrid; CHF 150,000 - 230,000; Full time

Job summary

elemed is seeking a Regulatory Affairs Manager (EU) in Zug, working hybrid with 2 days from home per week. You will lead the CE marking for a Class III implant and serve as the regulatory lead across R&D, quality and manufacturing.

You will manage the notified body relationship, drive MDR submissions, and guide the regulatory strategy globally. A US trial may provide FDA exposure, with substantial clinical evidence supporting the CE submission.

Qualifications

• CE marking experience for Class III implants.
• Experience leading EU MDR submissions and regulatory strategy.
• Strong knowledge of ISO 13485 and quality systems.
• Ability to author regulatory submissions and technical documentation.
• Cross-functional collaboration with R&D, QA and manufacturing.

Responsibilities

• Lead and manage the full CE mark pathway under EU MDR.
• Own the relationship with the notified body through audits and submission.
• Draft, review and own regulatory submissions and labelling.
• Collaborate with R&D and quality on design controls and risk reviews.
• Support audit readiness and rollout of a new electronic QMS.
• Provide regulatory input to strategy and approval pathways.
• Monitor regulatory intelligence and assess impact on products.
• Assist US team on clinical trial aspects when capacity permits.

Skills

CE marking

MDR knowledge

Regulatory affairs

Quality assurance

ISO 13485

21 CFR 820

510K / PMA

Digital health

Labelling

Risk management

Job description

elemed is seeking a Regulatory Affairs Manager (EU) in Zug, working hybrid with 2 days from home per week. You will lead the CE marking for a Class III implant and serve as the regulatory lead across R&D, quality and manufacturing.

You will manage the notified body relationship, drive MDR submissions, and guide the regulatory strategy globally. A US trial may provide FDA exposure, with substantial clinical evidence supporting the CE submission.