Quality, Regulatory, Clinical Affairs Manager (20~40%)
11.02 2025
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 60601 and 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:
* CV
* Certificates (e.g. ISO13485 auditor)
* 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.
More information here
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