Refeyn
Qa Engineering
Overview
The Regulatory Affairs & Quality Assurance (RAQA) Director is responsible for the strategic development and execution of the company's regulatory affairs and quality assurance programs, general product compliance, and the administration of the electronic Quality Management System (eQMS).
About Refeyn
Refeyn is a high-tech company providing innovative instruments and solutions, transitioning from academic research into bioprocessing and industrial-scale biomanufacturing markets.
Requirements & Eligibility
- Comprehensive set of change management skills, experiences, and past successes
- Experience in global regulatory strategy, general product compliance, and quality management systems
- Openness to learn, adapt, and grow with the business
Key Responsibilities
- Develop, implement and manage Refeyn's global regulatory strategy to ensure compliance with applicable general product regulations across target markets.
- Own product labelling, technical documentation and declarations of conformity required for lawful sale as a research/laboratory instrument in each target market.
- Own export control classification and associated compliance for international shipping of instruments and components.
- Monitor evolving customer use-cases, claims and markets to determine regulatory obligations.
- Manage regulatory agents/distributors and associated registration renewals across global markets.
- Keep abreast of industry developments, forthcoming regulations, guidance, and best practices.
- Own and administer Refeyn's eQMS, ensuring it meets required standards.
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