QA (Quality Assurance) / RA (Regulatory Affairs) Specialist for Medical Devices
An exciting Israeli startup company is seeking an experienced QA specialist, with potential for a combined RA role.
The qualified candidate will be responsible for:
Compliance of the company’s processes and products to any mandatory quality/regulatory requirements set by the organization. Work with contractors and cross-functional teams to ensure the safe design and manufacture of product throughout the product life cycle Handling of quality functions (mandatory), potentially in combination with regulatory affairs responsibilities in a hybrid role (not mandatory but advantageous). Support efforts on behalf of the QA and RA Manager to build and maintain aspects of the quality assurance and regulatory roadmaps
Maintaining the ISO 13485 quality system with the 21 CFR 820 QSR, including documentation control, change control, design controls, complaint handling, non-conforming products, CAPA, etc. Assure that future design changes and updates are aligned with company procedures.
RA (not mandatory but advantageous):
Compile packages for regulatory submissions, including FDA , CE technical files. Communicate with regulatory agencies and authorized testing lab regarding compliance and implementation of requirements, follow-up of submissions under review.
3+ years of experience in QA of medical device functions. Solid understanding and proven of ISO 13485, 21 CFR 820 QSR, ISO 14971, IEC 60601, IEC 62304 and software development lifecycle. Verbal and technical writing skills. Advantageous:
Proven experience with regulatory submissions and obtaining regulatory approvals/clearances (advantageous)
Bachelors Degree required (preferably in a scientific field) or equivalent in work experience
Required Skills, Knowledge and Characteristics:
Highly motivated, committed and responsible Ability to work independently and as part of a team efficiently to meet deadlines, Proactive Effective verbal communication and writing skills Strong familiarity with software development lifecycle