Quality and Regulatory Affairs Manager

Remote opportunity

Please note that to work remotely, you should be a resident of the country specified in the job description.

We are looking for you!

The client supplies design, development and support to medical device manufacturers. They are a supplier of the ins2outs – a quality management system platform that includes fully defined know-how sets for ISO 13485, MDR, and 21 CFR 820. They are developing various SaMD-type products up to class III risk classification and also have a dedicated team that provides regulatory consulting services.

Skills and experience you can bring to this role!

Qualifications and experience:

  • 3+ years experience in quality management (ISO 13485 or ISO 9001);
  • Proven track record working in a quality manager or regulatory affairs positions;
  • Have a good understanding of ISO 13485, ISO 14971;
  • Business fluency in English (both spoken and written);
  • Excellent communication, organizational, leadership and interpersonal skills; and
  • Enthusiastic, goal-oriented and problem-solving attitude.

Added advantage:

  • Understanding of the IEC 62304 standard and the software development life cycle; and
  • Experience in MDR and IVDR regulations.

What impact you’ll make

  • Managing ISO13485 compliant quality management system(s) (QMS) of Star or our clients;
  • Act as the management representative with notified bodies and market regulators;
  • Coordinating activities related to the QMS;
  • Supporting the engineering and service provision team in the development and delivery of safe medical devices;
  • Defining and executing regulatory strategies for medical device-type products (mostly software as a medical device);
  • Supporting product teams in the preparation of technical documentation for medical devices and the market approval process;
  • Communicating, educating and building awareness about the QMS in the organization;
  • Conducting audits and supporting the organization’s efforts to achieve quality goals; and
  • Continuously improving the QMS definition in the organization.

What you’ll get

Regardless of your position or role, we have in place a wide array of benefits including flexible working (hybrid/remote models) and generous time off policies (unlimited vacations, sick and parental leaves) to make it easier for all people to thrive and succeed at Star. On top of that, we offer an extensive rewarding and compensation package, intellectually and creatively stimulating space, health insurance and some more.

Your holistic wellbeing is central at Star. You'll join a warm and vibrant multinational environment filled with impactful projects, career development opportunities, mentorship and training programs, fun sports activities, workshops, networking and outdoor meet-ups.

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Who we are

We champion empathic and passionate craftspeople who make the world a better place with high-caliber ideas and products. Our growing strong Star Crew takes immense pride in working side by side with the world’s most disruptive “unicorn” startups and iconic global brands.

Star is an Equal Opportunity Employer. We believe that equity, diversity and inclusion are key to our ability to provide our clients and crew members with unique business and career outcomes. Your race, color, ancestry, religion, gender, identity, sexual orientation, age, marital status, or disability have no effect on our hiring decisions. If you have a special need that requires accommodation, please let us know

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