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 global consultancy that does not have a headquarters location. Instead, we have many front doors, spanning Silicon Valley, Tokyo, London, Munich, Milan, Copenhagen, Kyiv, Wroclaw, Ho Chi Minh City, and other design, technology, and creative hubs around the world.
Our spirited and growing Star Crew takes great pride in working side-by-side with their counterparts at some of the world’s most disruptive “unicorn” startups and iconic brands like Lufthansa, NTT Data, Paidy, Zeiss, Xerox, Panasonic, Walmart, Analog Devices, BMW Group, SAIC, NIO, Skin Analytics, Lotus and Dolby.
Our mission is to make every great person, every great idea and every great company shine. That’s why we’re called Star.
We are looking for you!
A Director of Quality and Regulatory Affairs who could lead Star’s Regulatory Consulting team and support Star’s global software development consulting services, providing team leadership, pre-sales, and project delivery support with regulatory and compliance guidance.
Skills and experience you can bring to this role!
Qualifications and experience:
- Bachelor’s degree, preferably in a medical, engineering or science field;
- Advanced, professional-level written and verbal English and excellent communication skills;
- 5+ years of Quality Assurance and/or Regulatory Affairs experience working in the medical device/regulated software field or a regulatory, submissions or quality support role;
- Thorough knowledge and understanding of medical device quality system requirements (e.g., FDA, CE, ISO 13485, MDR/IVDR, IEC 62304, IEC 62366); and
- Able to speak in depth on ISO 13485 and 14971 requirements.
- You have an academic background in a technical or scientific field (e.g., software engineering, biochemistry, biological engineering, chemistry or similar);
- You have gained at least 10 years of experience working in Regulatory Affairs in the medical device or diagnostics industry;
- Expertise in IVDs is considered a plus;
- Consulting experience is a plus; and
- Excellent attention to detail, research, or device registration experience is a plus.
What impact you’ll make
- Work with and guide the pre-sales team and customer to align on a strategy that meets the client’s business needs while satisfying regulatory constraints;
- Providing guidance to the pre-sales team(e.g., in determining the scope and budget of proposals);
- Develop and leverage knowledge of requirements and expectations for software as a medical device (SaMD) or software in a medical device (SiMD) submission, understand the registration process, including whether tasks should be completed concurrently or sequentially and clearly delineate each process/phase to clients;
- Take part in the definition of the product's intended purpose, regulatory strategy, and product requirements, identifying harmonized standards and a path to market (US, Canada, EU);
- Assist with client documentation reviews and gap analysis, provide input regarding the acceptability of existing data, and explain how to satisfy the submission requirements.;
- Serve as an escalation point for more complex regulatory issues identified by the team or client;
- Serve as the lead consultant on multi-market projects where needed;
- Customize consulting solutions to client's specific needs (on-site and off-site);
- Participate in the development and maintenance of internal Star programs and processes;
- Review marketing material for accuracy (e.g., articles, case studies, and website content);
- Handle client inquiries and provide consultation regarding software as a medical device quality assurance and regulatory compliance issues, such as drafting and reviewing mandatory documents or operating procedures needed for quality assurance or regulatory compliance;
- Manage issues arising from registrar or regulatory inspections/audits; and
- Act as regulatory support on larger project teams.
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.
Who we are
We champion empathetic and passionate craftspeople who make the world a better place with high-caliber ideas and products. Our growing 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.