Quality, Regulatory, Clinical Affairs Manager

vor 7 Stunden

Lausanne, Schweiz The Biopôle Vollzeit

Jobs > Quality, Regulatory, Clinical Affairs Manager (20~40%)

06.01
2025

Quality, Regulatory, Clinical Affairs Manager (20~40%)COMPANY DESCRIPTION
Emovo Care is a medical device company developing robotic systems to support people with motor impairments. We are a small team passionate about leaving a dent. Beyond restoring function, our mission focuses on promoting inclusion for people with disabilities through employment, community, and co-creation.

Our first product is an exoskeleton to support individuals with reduced hand function e.g. after a stroke.

JOB DESCRIPTION
We’re seeking a meticulous Quality, Regulatory, Clinical Affairs Manager to join our passionate, hard-working team.

This role is ideal for someone with strong experience and interest in medical device regulations, quality management systems, and clinical operations, paired with a pragmatic mindset and exceptional attention to detail.

KEY RESPONSIBILITIES
  1. Maintain and improve our ISO 13485-, 21 CFR Part 820-, and MDR-compliant Quality Management System (QMS)
  2. Lead the transition from a paper-based to a digital (eQMS) system, in a cost-effective manner (e.g. using process validation methodologies)
  3. Coordinate with the engineering team to compile and maintain technical documentation for current and future products (Class I to IIa) in compliance with relevant standards (e.g., MDR, ISO 60601)
  4. Manage communications with regulatory stakeholders, including authorized representatives, notified bodies, external consultants
  5. Prepare for audits and represent the company during audits (currently limited to one internal audit per year)
  6. Serve as Person Responsible for Regulatory Compliance (PRRC)
  7. Ensure compliance of clinical operations (e.g. manage enrollment and reporting in clinical studies)

JOB REQUIREMENTS
  1. Ph.D., Master’s or Bachelor’s degree in relevant field (e.g., bioengineering). Non-engineering degrees are acceptable with sufficient related work experience
  2. At least 3 years of professional experience in regulatory affairs or quality management systems for medical devices (5 years if the degree is not in a relevant field)
  3. Proven experience working with relevant standards and regulations, including ISO 13485, ISO 14971, MDR, and 21 CFR Part 820
  4. Familiarity with ISO 60601 and electromechanical medical devices is a plus
  5. Prior experience in a lead role managing external audits with notified bodies
  6. Relevant QRA certifications, such as ISO 13485:2016 internal auditor
  7. Interest in risk management and risk-based approaches (e.g., ISO 14971)
  8. Experience in clinical operations (e.g. manage clinical studies: enrollment, reporting, compliance)
  9. Excellent English communication skills, both written and verbal
  10. Positive, team-oriented mindset with a passion for creating products that make a meaningful impact on people’s lives
  11. Strong organizational skills with the ability to manage tasks effectively while collaborating in a fast-paced team environment
  12. Residing in the European Union or Schengen area with a valid work permit
  13. (If remote:) Willing and able to travel to Lausanne, Switzerland, quarterly
  14. (If remote:) Open to working as an independent contractor

OUR OFFER
  1. Flexibility to work fully remote as an independent contractor (EU/Schengen-based only), or in-person in scenic Lausanne as a Swiss employee
  2. Part-time, flexible work schedules that support work-life balance while maintaining team collaboration in a passionate, dynamic team
  3. Occasional travel to Switzerland (approximately once per quarter), with travel and accommodation covered (if remotely located)
  4. A unique opportunity to shape the regulatory strategy in an early-stage impact start-up

INTERESTED?
Send the following to jobs@emovocare.com:
  1. CV
  2. Certificates (e.g. ISO13485 auditor)
  3. Brief motivation (in the email) explaining why you’re a great fit for this role

While we might require references later, you’re welcome to include them upfront in your application. #J-18808-Ljbffr

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