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Regulatory Compliance specialist

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Spectrum Dynamics Medical is engaged in the development, manufacturing, sale, and service of state-of-the-art nuclear medicine imaging systems. 

We are spearheading the transformation of the Single Photon Emission Computed Tomography imaging systems from analog to digital detection technology, enabling hospitals and clinicians to provide superior healthcare services at a much lower cost. 

Position Responsibilities 

  • Ensures implementation and maintenance of required Medical Device Certifications and Technical Documentation reviews for products manufactured by the company in accordance with MDSAP/MDR/ISO, applicable regulatory requirements, and the Corporate Quality Manual.
  • Accountable for the escalation of quality & compliance issues associated with Medical Devices to management in accordance to company requirements and drive the implementation of remediation actions in a timely and robust manner.
  • Communication and interface with external contacts were appropriate: suppliers, subcontractors, Health Authorities.
  • QA release of Medical Devices.
  • Review and approval of compliance and contractual documents (QA Agreements, Certifications)
  • Responsible for product assessments, Medical Device Reporting, and recall activities per the global standards and policies.
  • Health Agency interface (including Notified Bodies)
  • Periodic Review and Reporting of Compliance Status and Quality Compliance KPIs, CAPAs

Experiences, Knowledge, Skills and Abilities 

  • Graduate in Engineering/Chemistry/Pharmacy/Microbiology/Biotechnology or another related science
  • English fluent in speaking/writing.
  • At least 3 years of relevant experience
  • Ability to influence people, negotiate and communicate
  • Sound scientific, technical, and regulatory knowledge in the Medical Device area
  • Experiences with health authorities and notified bodies
  • Good compliance knowledge of MDSAP/MDR/ISO, working knowledge of medical device regulations, standards, and guidelines
  • Good knowledge of medical device compliance for development and life-cycle management
  • Excellent organizational skills
  • Good and proven ability to analyze and evaluate quality and regulatory compliance

Applications 
Please submit job applications by email to [email protected]

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