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Senior Regulatory Compliance Officer
- Regulatory Affairs
About Our Client
Our client is a fast growing company specialised in the IVD industry.
- Be the main point of contact for regulatory compliance issues
- Establish, implement and maintain the post-market surveillance process
- Lead and coordinate the vigilance process in interface with the complaint handling process
- Interface with Competent Authorities for reporting incidents, and field safety actions, including FSCA, FSN,
recalls, MDRs (medical device reporting), BPDR (Biological Products Deviation Reports)
- Evaluate changes for compliance to regulatory requirements and ensure changes are communicated in a
timely basis as appropriate to the Regulatory Authorities (change control)
- Evaluate Product/Processes Non-Conformances, determine their impact on regulatory submissions,
determine whether their need to be reported to the Competent Authorities
- Establish, implement and maintain regulatory processes, such as industry regulatory and standards watch
and their implementation within the Quality Management System
The Successful Applicant
- Master degree or equivalent in life sciences and 5 years of experience in a regulatory affairs role
- Experience in medical device / IVD / biotech industry
- Significant 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 with a thorough and methodical approach to work.
- Strong verbal and written communications with ability to effectively communicate at multiple levels in
- Manage Site registration process for US, EU and other jurisdictions as appropriate.
What's on Offer
Great Opportunity to join a dynamic team on very innovative products.