JOB OFFER

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

[Latest update: 16 January 2025. Status: Open]

COMPANY DESCRIPTION

Emovo Care (www.emovocare.com) 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:

  • Maintain and improve our ISO 13485-, 21 CFR Part 820-, and MDR-compliant Quality Management System (QMS)

  • Lead the transition from a paper-based to a digital (eQMS) system, in a cost-effective manner (e.g. using process validation methodologies)

  • 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)

  • Manage communications with regulatory stakeholders, including authorized representatives, notified bodies, external consultants

  • Prepare for audits and represent the company during audits (currently limited to one internal audit per year)

  • Serve as Person Responsible for Regulatory Compliance (PRRC)

  • Ensure compliance of clinical operations (e.g. manage enrollment and reporting in clinical studies)

JOB REQUIREMENTS

  • Ph.D., Master’s or Bachelor’s degree in relevant field (e.g., bioengineering). Non-engineering degrees are acceptable with sufficient related work experience

  • 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)

  • Proven experience working with relevant standards and regulations, including ISO 13485, ISO 14971, MDR, and 21 CFR Part 820

  • Familiarity with ISO 60601and electromechanical medical devices is a plus

  • Prior experience in a lead role managing external audits with notified bodies

  • Relevant QRA certifications, such as ISO 13485:2016 internal auditor

  • Interest in risk management and risk-based approaches (e.g., ISO 14971)

  • Experience in clinical operations (e.g. manage clinical studies: enrollment, reporting, compliance)

  • Excellent English communication skills, both written and verbal

  • Positive, team-oriented mindset with a passion for creating products that make a meaningful impact on people’s lives

  • Strong organizational skills with the ability to manage tasks effectively while collaborating in a fast-paced team environment

  • Residing in the European Union or Schengen area with a valid work permit

  • (If remote:) Willing and able to travel to Lausanne, Switzerland, quarterly

  • (If remote:) Open to working as an independent contractor

OUR OFFER

  • Flexibility to work fully remote as an independent contractor (EU/Schengen-based only), or in-person in scenic Lausanne as a Swiss employee

  • Part-time, flexible work schedules that support work-life balance while maintaining team collaboration in a passionate, dynamic team

  • Occasional travel to Switzerland (approximately once per quarter), with travel and accommodation covered (if remotely located)

  • 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.