Regulatory Compliance Specialist

3 weeks ago


Penicuik, Midlothian, United Kingdom AliveDx Full time
Job Description

Job Title: Regulatory Compliance Officer

Job Summary:

AliveDx is seeking a highly skilled Regulatory Compliance Officer to join our Regulatory Affairs team. As a key member of our team, you will be responsible for implementing and maintaining regulatory compliance processes, including regulatory evaluation of non-conformances, post-market surveillance, vigilance, and associated reporting.

Key Responsibilities:

  • Be the main contact for regulatory compliance issues
  • Provide PMS documentation according to IVDR requirements (PMS Plan, SSP, PMS Report, PSUR)
  • Lead and coordinate the vigilance process in interface with the complaint handling process
  • Liaise with regulatory authorities and external contract bodies and, in response to requests from these, collate and interpret specialized information
  • Interface with Competent Authorities for reporting incidents and field safety actions, including FSCA, FSN, recalls, MDRs (medical device reporting), BPDR (biological products deviation reports)
  • Contribute to the regulatory watch process by maintaining knowledge of new or updated regulatory requirements, guidance documents, and industry standards

Requirements:

  • A relevant degree and/or relevant work experience in a regulatory affairs environment
  • Experience in medical device/IVD/Biotech industry
  • Experienced in meeting with, making presentations to, and negotiating with regulators
  • Specialist knowledge of regulation as applied to medical devices, in vitro diagnostic medical devices, or Biologics (93/42/EC, 98/79/EC directives, 510(k), PMA, BLA, CMDR, etc.)
  • Great attention to detail, communication, and collaboration skills

What We Offer:

  • A highly dynamic and growing environment
  • An opportunity to live your passion for intrapreneurial mindset, where cultivating innovation and customer centricity are at the heart of everything we do
  • A flexible working environment where applicable and a range of core and flexible benefits ranging from pension, private medical cover, life assurance, additional annual leave, cycle to work, technology, experience days, and access to marketplace discounts


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