Quality and Regulatory Affairs Manager

vor 1 Woche

Liestal, Schweiz HEMEX AG Vollzeit

HEMEX AG is committed to changing the future of healthcare by guiding the most promising European start-ups through each and every step to bring innovative pharmaceuticals, medical devices and in vitro diagnostics to the market. Headquartered close to the thriving Basel global Life Sciences hub, the goal at HEMEX is to ensure start-ups have access to a wide range of tailored products, practical solutions and fundraising support. This empowers the next generation of transformative discoveries to grow into successful and sustainable businesses, and drive change in both human and animal healthcare. For more information, visit our website.

Tasks
- The QA/RA Manager will be overall responsible for company’s QMS maintenance and regulatory compliance. In addition, the QA/RA Manager will also support HEMEX’s portfolio startups with Quality and Regulatory Affairs.
- Act as an all-round Subject Matter Expert regarding Quality and Regulatory Affairs with a sound knowledge of EU MDR 2017/745;
- Maintain the Quality Management System (QMS) of the company in compliance with ISO 9001 and ISO 13485;
- Provide interpretation of regulatory specific requirements to internal stakeholders;
- Support our broad portfolio of start-ups with developing and implementing their regulatory strategy to accelerate market access;
- Frequent communication with clients, regulatory authorities, ethics committee and institutional review boards in all continents;
- Manage/coordinate various regulatory process, including CE-marking and Market Authorization Applications;
- Support Sales Team with the preparation of cost proposals for clients;
- Maintain and update existing regulatory authorizations and licenses;
- Support with the maintenance of relevant regulations into Quality Management System procedures, and support during certification audits by regulatory bodies;
- Work with the multidisciplinary team to keep our clients informed of regulatory requirements and emerging issues which may affect the registration approval of their products.

**Requirements**:

- University degree in Medicine, Pharmacy, Life Sciences, or related discipline.
- At least 5 years’ experience in EU or US, in a regulated industry (pharmaceuticals, biologics, medical devices) with excellent knowledge of international regulatory standards in the areas of medical device quality, safety, and efficacy. Knowledge of international regulations EMEA, LATAM, other regions are a plus.
- Strong interpersonal skills, maturity, persuasiveness and a high level of discretion.
- Efficient working style and hands-on “start-up” mentality.
- Excellent knowledge of MS Office tools (Word, Excel, Outlook,).
- Be results oriented and have a ‘can do' attitude, with excellent problem solving capacity.
- Based in North-western Switzerland region.
- Fluency in written and verbal English are a must.
- Fluent in German, French and/or Italian; additional languages are an added benefit.

**Benefits**:
HEMEX is an equal opportunity employer. All employment is decided on the basis of qualifications, merit and business need. We are committed to providing a truly diverse and inclusive workplace that supports, inspires, and respects all individuals.
- Join a highly motivated and skilled team working on a variety of medical innovations,
- Office-based employment in Liestal (Switzerland),
- Pleasant working environment in a dynamic organization.

If you meet the described profile, we look forward to receiving your CV and supporting documents in English.

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