Senior Manager Regulatory Affairs

elemed; Zug; Ibrido; CHF 150.000 - 230.000; Tempo pieno

Descrizione del lavoro

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.

Competenze

• 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.

Mansioni

• 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.

Conoscenze

CE marking

MDR knowledge

Regulatory affairs

Quality assurance

ISO 13485

21 CFR 820

510K / PMA

Digital health

Labelling

Risk management

Descrizione del lavoro

Regulatory Affairs Manager (EU)

Location: Zug, hybrid, 2 days work from home per week

Contact: [e-mail]

Mandatory experience: CE marking of a CLASS III implant

Do you want to be the person who takes a first-of-its-kind medical device through CE marking, from setting up the notified body to the final submission? ( and build a pathway very few people in the industry will ever have on their CV.)

Are you happiest in a small team where you write the submissions yourself and see them through to approval?

The company

This is a well-funded MedTech start-up with long-term private backing. Its investors have stayed committed through the hardest phases of development, so you get the pace and freedom of a start-up without the usual worry about the next funding round.

The team is small, experienced and international, with very little politics. The CEO is hands-off and decisions are made as a team, so you own your work and can move quickly.

Do you love working somewhere your judgement is trusted from day one? Strategy is decided together rather than handed down, so your judgement shapes the direction of the product.

The business sits within a wider group of healthcare companies. That gives you shared facilities and a far bigger professional network than the company's size suggests. It is a mission-led business focused on families' health, so your work has a clear patient purpose.

The Opportunity

As Regulatory Affairs Manager (EU), you will be the regulatory lead for a Class III implantable device with no direct equivalent on the market. You will run the CE mark work under the MDR day to day, from notified body onboarding in early 2027 through audit readiness and submission. In short, you will lead the whole CE marking programme, not just “a piece” of it.

You will be the main contact for the notified body and the go-to regulatory partner for R&D, quality, manufacturing and clinical colleagues. You will work closely with the VP of Clinical and Regulatory, who leads global strategy and FDA work, so your hands-on experience feeds straight into the regulatory plan.

A US clinical trial is running alongside the European work. If you want it, you can get close exposure to an FDA pathway, from reviewing documents to helping answer regulator questions with the US team.

Years of follow-up data on the earlier version of the device support the case, so you build the CE mark submission on solid clinical evidence.

The successful applicant is a senior doer who enjoys owning the detail, from technical files to labelling. Are you the kind of Regulatory Affairs Manager who works out the answer when nobody has it yet?

You will be in the office three days a week, with the rest flexible, so you get time with the team and time to focus.

Your responsibilities

• Lead and project manage the full CE mark pathway under the EU MDR, keeping the plan on track as priorities change
• Own the relationship with the notified body, from onboarding through audits and submission
• Write, review and own technical documentation and regulatory submissions, including labelling
• Partner with R&D and quality on design controls, risk management reviews and change assessments
• Support quality with audit readiness and the rollout of a new electronic QMS
• Give operational input to the VP of Clinical and Regulatory on regulatory strategy and approval pathways
• Monitor regulatory intelligence and assess how new requirements affect the products
• Help the US team on the clinical trial side when you have capacity

Please note: Due to the high volume of applications we sometimes receive, our team might not be able to contact each applicant individually regarding the status of their application. If you do not hear from us after 10 days, please consider your application unsuccessful.

Key skills we recruit for:

ISO 13485, 21 CFR 820, CE marking, MDR, Medical device regulation, MDD, medical devices, Digital health, 510 (K), PMA, Regulatory affairs, quality assurance, QA/RA, design quality, ISO 14971, combination devices, sterilisation, AIMDD, CER, PMCF