Role: Regulatory Affairs Director
Location: Zurich (candidate must be based in Switzerland and able to commute to the office – hybrid). Relocation is not supported for this role.
If you’re a Senior Manager ready to step up into a Director-level role, or an established Director who is all about team enablement, this is for you. If you are at that inflection point in your career and want to lead rather than execute tactically, this is a concrete opportunity to do exactly that.
The Company This is a private small medical device company which means two things in practice: decisions are made with a long‑term view rather than in response to quarterly big blue chip pressures, and you would be working steps away from the development team whose product you are helping to bring to market – and working with all team members in a small and close knit startup culture.
The Culture The culture here is fast paced and values people who act as partners to the business rather than gatekeepers. The expectation is that Regulatory Affairs enables innovation, not that it slows it down.
The Opportunity This is a role focused on leadership, and achieving success through enabling and challenging the team so they can grow.
The role reports directly to the VP QA and RA, making you the most senior regulatory voice on all product regulatory topics globally. The strategic remit is worldwide.
What You'll Be Doing
Lead, mentor and develop a team of Regulatory Affairs professionals that cover all aspects of regulatory globally.
Design and implement global regulatory strategies for new product development and the ongoing product lifecycle across a mixed portfolio of medical devices.
Oversee 510(k) submissions and manage product approvals and registrations across major markets – EU, US, Canada, Brazil, Australia, China, Japan, etc.
Collaborate closely with R&D, clinical and commercial teams to provide strategic regulatory input from early development through to market release.
What We're Looking For
Proven experience leading and developing a Regulatory Affairs team within the medical device industry.
Proven track record of growing people as well as delivering outcomes.
Solid technical grounding in global regulatory submissions including 510(k), with working knowledge of EU MDR and international registration requirements.
Contact To apply, send your CV to elena@elemed.eu.
#J-18808-Ljbffr
Location: Zurich (candidate must be based in Switzerland and able to commute to the office – hybrid). Relocation is not supported for this role.
If you’re a Senior Manager ready to step up into a Director-level role, or an established Director who is all about team enablement, this is for you. If you are at that inflection point in your career and want to lead rather than execute tactically, this is a concrete opportunity to do exactly that.
The Company This is a private small medical device company which means two things in practice: decisions are made with a long‑term view rather than in response to quarterly big blue chip pressures, and you would be working steps away from the development team whose product you are helping to bring to market – and working with all team members in a small and close knit startup culture.
The Culture The culture here is fast paced and values people who act as partners to the business rather than gatekeepers. The expectation is that Regulatory Affairs enables innovation, not that it slows it down.
The Opportunity This is a role focused on leadership, and achieving success through enabling and challenging the team so they can grow.
The role reports directly to the VP QA and RA, making you the most senior regulatory voice on all product regulatory topics globally. The strategic remit is worldwide.
What You'll Be Doing
Lead, mentor and develop a team of Regulatory Affairs professionals that cover all aspects of regulatory globally.
Design and implement global regulatory strategies for new product development and the ongoing product lifecycle across a mixed portfolio of medical devices.
Oversee 510(k) submissions and manage product approvals and registrations across major markets – EU, US, Canada, Brazil, Australia, China, Japan, etc.
Collaborate closely with R&D, clinical and commercial teams to provide strategic regulatory input from early development through to market release.
What We're Looking For
Proven experience leading and developing a Regulatory Affairs team within the medical device industry.
Proven track record of growing people as well as delivering outcomes.
Solid technical grounding in global regulatory submissions including 510(k), with working knowledge of EU MDR and international registration requirements.
Contact To apply, send your CV to elena@elemed.eu.
#J-18808-Ljbffr
