Regulatory Affairs Manager

3 days ago


Walton on the Hill, United Kingdom PE Global Full time

PE Global is recruiting a Regulatory Affairs Product Manager for our personal care product client on an initial 6-month contract. This role is based in Walton Oaks and has a hybrid work model.


Responsibilities of the role:


  • Review & submit accurate regulatory submissions to secure timely approvals in support of business initiatives.
  • Follow Regulatory Intelligence process to monitor the development of regulatory changes and communicate potential business impact to senior management.
  • Lead regulatory agency engagement and respond to inquiries to ensure that registrations renewals and approvals are granted without delay.
  • Participate in review of products sold in NA that are less regulated to ensure boundary adherence.
  • Provide regulatory support for post market assessments & reporting.
  • Assist in the resolution of regulatory and/or quality issues including providing recommendations for corrective action.
  • Ensure required Declarations of Conformity are created and posted as required for CE & UKCA marked products.
  • Provide regulatory support as required for planned or unplanned audits.
  • Provide advice regarding compliance with FDA and Health Canada Quality System and GMP requirements, as required.


Requirements:


  • CE & UKCA certification and maintenance for Category I, II & III products
  • US FDA medical device products including maintenance of regulatory registrations and listings including but not limited to NIOSH Approvals, FDA 510(k)
  • Health Canada device submissions
  • Knowledge of QSR/GMP regulations
  • There will be work required for US and therefore candidates would be required to be flexible on working hours - Flexitime would be arranged for these days.


Interested candidates should submit an updated CV.


***Please note our client cannot assist with any visa sponsorship and candidates must have the correct visa to live and work in UK***



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