- Provide QA functional expertise in the review of QMS processes for compliance to regulations, standards and guidelines related to Medical Device Software.
- Manage portfolio of assigned projects, support a discipline and/or provide a service on his/her own or with a team of associates. - Provide functional expertise in area of responsibility for medical device software.
- Ensure that new medical device software products including web-based and mobile applications are developed, commercialized and maintained through its lifetime in compliance with medical device, software and data security regulations and standards.
- Write, review and approve deliverables (e.g. procedures, records, device documentation) and related tools (e.g. IT, document systems, training tools) to ensure compliance to medical device and software regulations and standards.
- Improve the overall quality of medical device software, tools and procedures, including peer reviews.
- Manage quality problems and technical matters and ensure they are resolved consistently and in accordance with global standards and policies.
- Represent MD Quality in initiatives and cross-divisional projects.
- Support inspections and audits as required.
- Support a culture of high performance and trust. Assure that the required level of knowledge and skills is available and identify competency gaps. Establish and implement training and development plans.
- Meet internal and external guidelines regarding quality, safety and security (quality manuals, regulatory cGMP guidelines, health authority requirements, international standards, SOPs, HSE, etc.). Promote and enforce compliance to guidelines.
- Support project management functions as a sub-team member in preparation for a Inspection.
- Write/contribute to internal compliance policy and/or comment to regulations.
- At least 3 years of relevant experience.
- Practical experience in managing projects in compliance with ISO 13485, 21 CFR part 820 / part 4, IEC 62304, IEC 82304, ISO 14971, IEC 62366, MDD/MDR, GDPR and other relevant standards and guidances related to medical device software.
- Ability to influence people, negotiate and communicate.
- Sound scientific, technical and regulatory knowledge in a specific area.
- Excellent knowledge of cGMP, working knowledge of medical device software regulations, standards and guidelines.
- Good knowledge of medical device software development and life-cycle management.
- Good organizational skills.
- Good and proven ability to analyze and evaluate GMP compliance.
- Ability to work in cross-functional teams including Quality, Technical Development , Regulatory, Human Factors, Risk Management, IT and other functions
Education: Graduate in a scientific field. Medical device software background.
Languages: English fluent in speaking / writing, German and/or French desirable.