Regulatory and Quality Manager

Roles and responsibilities:
– Responsibility for the development, planning, and implementation of Company regulatory, clinical, and quality strategies in compliance and in support of company business objectives.
– In-depth knowledge of company products, identification and adaptation of various regulatory requirements in the various stages of the product development (from design requirements, to product release, to post-market surveillance).
– In-depth familiarity with t company business plans, ensuring alignment of regulatory pathway in support of business objectives and go-to-market strategy.
– Responsibility for Quality System planning, implementation, and ongoing maintenance, in compliance with applicable regulatory requirements (FDA QSR and ISO13485), including internal and external audits and inspections.
– Ongoing review, identification, and implementation of applicable regulatory requirements and international standards, as applicable, including SW Life Cycle Development standards, IT Security (ISO27001), etc.
– Perform ongoing communication and negotiation with local and foreign regulatory authorities, to understand the various regulatory requirements to be implemented in company processes and product requirements and obtain strategic agreement and understandings.
– Preparation and coordination of any correspondence and submissions to applicable regulatory authorities, such as FDA, CE, safety reports, technical file, 510 (k) and more.
– Support the development and conduct of company Clinical program to ensure alignment with and support of company business and regulatory strategies.
– Support development, implementation, and ongoing maintenance of Clinical Quality System per applicable regulatory requirements (GCP, ISO14155, as applicable) and ensure compliant conduct and monitoring of clinical studies.
– Close cooperation with all departments in the company: business development, marketing, clinical, R&D, and other.
– Raise awareness, educate, and train company employees on medical industry regulatory and quality environment and requirements.
Required education and work experience:
– BA in Life Sciences or Engineering
– At least 6 years of experience in regulatory positions in the medical device industry – preferably digital health / medical software / IVD products.
– Ability to work independently and lead strategic and significant processes in an organization.
– Proven experience in international regulatory applications – strategic planning, writing, and preparation and product registration (FDA, CE).
– Proven experience in Quality System set up, from procedures writing, implementation, training, to audits and certification.
– Experience working with regulatory departments of large technology companies in the field of medical devices and/or IVD.
– Independent and self-learning capabilities and ability to work under pressure and time constraints.
– Experience and knowledge in US Reimbursement processes – an advantage
– Fluent English.