All offersWrocławAdminQuality and Regulatory Affairs Manager
Quality and Regulatory Affairs Manager
Admin
Star

Quality and Regulatory Affairs Manager

Star
Wrocław
Type of work
Undetermined
Experience
Mid
Employment Type
B2B
Operating mode
Office

Tech stack

    Administrative
    regular

Job description


The Company

At Star, we connect strategy, insights, design and engineering into a seamless workflow devised to support our clients every step of the way—no matter how long or complex their journey. We anchor everything we do in clear and compelling endgames, which in turn enable our multidisciplinary teams to create superior solutions and impressive commercial returns for our clients.

Star is truly global. That is why we are the first major consulting company that does not have headquarters. Instead, we have many front doors spanning Silicon Valley, Tokyo, London, Munich, Copenhagen, Kyiv, Wroclaw, Ho Chi Minh City and other vibrant design, technology and creative nuclei of the world. Our spirited and growing 750+ strong Star Crew takes great pride in working side by side with their trailblazing counterparts at some of the world’s most disruptive “unicorn” startups and iconic global brands like Lufthansa, Dolby Laboratories, BMW, Panasonic, Walmart and Zeiss. 

Our mission is to make every great person, every great idea, and every great company shine. That’s why we’re called Star.

The Opportunity

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


Responsibilities

  • 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 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.

You

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;
  • Enthusiastic, goal-oriented and problem-solving attitude.
Would be a plus:

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

Compensations and Benefits

We offer a rewarding compensation and benefits package, intellectually and creatively stimulating environment, professional flexibility and unique international travel opportunities.

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, disability have no effect on our hiring decisions. If you have a special need that requires accommodation, please let us know.