Description
On behalf of our Global Medical Device client, we have an opening for an experienced Medical Device expert who will take on the responsibility of overseeing the Development activities of Medical Device as Software to ensure Quality systems are applied throughout the product life-cycle. As an Expert you will ensure development and commercialization of Medical Device Software Projects are conducted in accordance with Quality System requirements, ensuring high product quality, regulatory compliance and operational efficiency.Responsibilities:
- Manage portfolio of projects by providing functional expertise 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.
- 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. .
Requirements:
- 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, IEC 62304, IEC 82304, 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
Kontakt: Luchele Mendes
Michael Bailey International is acting as an Employment Business in relation to this vacancy.