Regulatory Affairs Specialist
October 4
Description
• Ensures compliance requirements according to 21CFR part 820, Regulation (EU) 2017/745, ISO 13485, and the company quality manual. • Ensures in close collaboration with design and engineering teams that all product realization processes are applied, and the product is compliant. • Coordinate the efforts associated with the preparation of regulatory documents for international regulatory submissions • Prepare and maintain technical documentation and certificates as necessary to obtain and sustain product approval • Communicate with regulatory agencies and testing laboratories regarding submissions, compliance test requirements and testing, and follow-up of submissions under review • Advise engineering project teams and manufacturing on regulatory and labeling requirements • Extend and maintain the knowledge on existing and emerging international and local regulations, standards, or guidance documents • Conduct gap analysis for new standards and regulations • Analyze product complaints and make recommendations regarding their reportability
Requirements
• MSc. or BSc. degree in engineering/science/law • Experience in international standards and government regulations • Experience with medical devices, preferably in radiation emitting devices, or wireless communication is a plus • Experience of working and communicating with different regulatory authorities and corresponding relationships is an additional plus that may complete your profile • Excellent communication skills in English, in writing and verbally • You are analytical, communicative and focused. • You work in a structured way and have an eye for details. • You can express your ideas and research in written form. • You are used to working independently, open to discussing ideas and solutions with your colleagues. • You thrive in an international work environment and in cultivating your contacts with partners in Europe and overseas.
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