Regulatory Affairs & Clinical Research Expert (80-100%)
Level: Manager / Senior Manager
Employment Type: long term Permanent Employment
Location: Zürich (Hybrid)
Start Date: Open for discussion
About the role:
As a Regulatory Affairs and Clinical Research specialist, you contribute to product development, clinical evidence generation, regulatory approval, and global market access. You ensure that products meet the clinical, regulatory, and reimbursement requirements necessary for successful market entry and sustained performance.
Key Responsibilities
Regulatory Affairs
* Contribute to development projects for medical device innovations.
* Prepare and manage regulatory submissions for EU, US, and APAC markets.
* Communicate with regulatory authorities and manage related correspondence.
* Participate in audits and inspections.
* Contribute to QMS activities, including maintaining quality documentation and supporting internal training and compliance.
Clinical Research & Evidence
* Understand product impact on users, patients, outcomes, and cost‑effectiveness.
* Define, prioritize, and execute clinical evidence strategies (pre‑ and post‑market).
* Develop and implement European clinical evidence plans with internal teams.
* Ensure clinical data supports regulatory, commercial, and market access needs.
Reimbursement & Market Access
* Collaborate on reimbursement strategies and innovative payment pathways
* Identify and advise on coding, tariff and funding opportunities
* Support and drive applications for positive reimbursement decisions
* Align clinical and economic evidence to demonstrate product value
Cross‑Functional Collaboration
* Work closely with Clinical, Regulatory, Market Access, and Commercial teams.
* Ensure alignment on evidence requirements across the product lifecycle.
* Act as a key interface between technical, clinical, and business stakeholders.
* Track and report clinical study milestones, budgets, and outcomes. Provide clear, structured updates to leadership and support decision‑making through data‑driven insights.
Profile Requirements
* Advanced degree (Master/PhD) in: Life Sciences, Medical/Biomedical Engineering, Natural Sciences or a related field
* 5-10 years of professional experience, including:
* Regulatory Affairs and/or Clinical Research within Medical Devices
* Strong ability to prioritize, meet deadlines, and work independently
* Solid knowledge of: EU MDR, ISO 13485 and ISO 14971, FDA 21 CFR Part 820, Global registration processes (EU / US / APAC)
Preferred qualifications:
* Certifications in Regulatory Affairs and/or Clinical Research (e.g., Clinical Evaluation)
* Strong interpersonal and professional skills
* Clear communication and stakeholder management
* Effective presentation and technical writing
* Entrepreneurial mindset and high ownership
* Fluent in English; German or other languages are a plus
Best regards from Zurich!
SThree_Germany is acting as an Employment Agency in relation to this vacancy.