Quality Management, Regulatory Affairs

5 days ago

Singapore Kinexcs Pte Ltd Full time $120,000 - $180,000 per year

Kinexcs is a multidisciplinary digital health start-up at the forefront of a rapidly booming industry. It is a data-driven digital therapy platform & wearables company to enable and empower people for mobility and a better life. Kinexcs strives to enable personalised health and evidence-based recovery for musculoskeletal patients.

Website: Kinexcs

Job Summary

We are seeking an experienced professional to lead Clinical Affairs, Quality Management, and Regulatory Compliance within our organization. The role will be responsible for managing clinical evaluations, ensuring compliance with global quality standards, and overseeing regulatory submissions across international markets.

Responsibilities

  1. Quality Management System (QMS) Leadership

  2. Develop, implement, and maintain QMS in compliance with global standards such as ISO 13485, ISO 9001, and other relevant certifications.

  3. Conduct internal and external audits, addressing non-conformities with robust corrective and preventive actions (CAPA).

  4. Establish quality policies and procedures, ensuring organization-wide adherence.

  5. Train employees on quality standards and foster a culture of continuous quality improvement.

  6. Regulatory Affairs Compliance

  7. Lead all regulatory submissions, registrations, and compliance activities for domestic and international markets.

  8. Ensure alignment with regulations such as FDA, CE, MDR, and other global standards.

  9. Stay updated on regulatory changes and implement required adjustments promptly.

  10. Act as the primary liaison with regulatory bodies, handling inspections, certifications, and reporting.

  11. Sales & Customer Success

  12. Identify and qualify leads, conduct product demos, and manage the full sales cycle.

  13. Maintain CRM records and collaborate with Marketing and Customer Success teams.

  14. Onboard new customers, provide training, and ensure product adoption.

  15. Build strong client relationships, act as a customer advocate, and address risks.

  16. Gather and relay customer feedback to product and engineering teams.

  17. Undertake business travel as required.

  18. Clinical Affairs Management

  19. Plan, coordinate, and manage clinical evaluations, including Clinical Evaluation Reports (CERs) in alignment with requirements.

  20. Support the design and execution of clinical studies, including post-market clinical follow-up (PMCF) where required.

  21. Collaborate with R&D, regulatory, and medical teams to collect, analyze, and report clinical data to support regulatory submissions.

  22. Maintain up-to-date clinical documentation and contribute to risk management and product lifecycle planning.

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