Regulatory Compliance Specialist for MedTech Innovation

Vor 3 Tagen

Dübendorf, Zürich, Schweiz Odne AG Vollzeit

About Odne AG

We are a pioneering MedTech startup founded in 2018 and ISO 13485 certified, revolutionizing the endodontic device market in the US and EU. Our mission is to develop cutting-edge solutions that help people keep their natural teeth longer.

Job Overview

We are seeking an experienced Quality & Regulatory Manager to join our dynamic team. As a key member, you will oversee our quality management system and ensure compliance with regulatory requirements.

Key Responsibilities:

  • Maintain, improve, and verify the effectiveness of our QMS according to ISO 13485 & 21 CFR 820.
  • Serve as Management Representative and Person Responsible for Regulatory Compliance (PRRC).
  • Handle non-conformities, change control, CAPAs, complaints, feedback, and vigilance activities, connecting internal and external stakeholders.
  • Plan, conduct, monitor, and evaluate management reviews, trainings, and audits (internal & supplier).
  • Manage interaction with notified bodies, the FDA, and other authorities.
  • Participate in qualification and validation activities, managing equipment and supplier qualifications.
  • Release raw materials and products, maintaining traceability systems.

Requirements:

  • Background in science or engineering, at least 5 years of experience in medical devices in quality or Q&R roles.
  • Thorough experience in setting up and maintaining QMS for medical devices; regulatory affairs (FDA and MDR) experience a plus.
  • Expert knowledge of applicable norms: EU MDR, ISO 13485, 21 CFR 820, ISO 14971.
  • Lead auditor experience in internal audits and supplier audits.
  • Ability to create documentation efficiently, excellent English language mastery.
  • High IT-proficiency, experience with MS SharePoint, MS Access, SQL, and/or PowerApps a plus.
  • Flexible mindset, autonomous, hands-on, solution-oriented working style.
  • Highly motivated, entrepreneurial, and responsible personality.

What We Offer:

  • A challenging role contributing to life-improving innovations.
  • The opportunity to shape our growing MedTech startup, support market launches, and growth phases.
  • A dynamic, international team of 10 people with a common goal.
  • Participation in company success through an attractive Employee Stock Ownership Plan (ESOP).
  • Flexible working hours, home office possibility, 25 days of holidays.
  • Well-located office close to the Stettbach station and highway.

We look forward to reviewing your application, including a brief cover letter explaining your motivation and suitability for this role.

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