Regulatory Affairs Specialist- 12-month contract-Hybrid working model
Reg Affairs Specialist required for a leading healthcare organisation in the South East. The Reg Affairs Specialist will lead and drive all MCC (manufacturing changes and controls) submission activities (planning, authoring, reviewing, coordination, submission). You will also support or manage Health Authority interactions on MCC issues. There is great potential for this role to move to a permanent/FTE position.
Overview of Main Responsibilities (full job description available on request):
Implement and drive MCC regulatory strategy for marketed devices with a focus on maximizing the business benefit balanced with regulatory compliance.
Lead and drive all MCC submission activities (planning, authoring, reviewing, coordination, submission) for assigned projects/products.
Make quality regulatory decisions, balancing risks and benefits.
Identify as early as possible, the required documentation and any content, quality and/or timeline issues.
Negotiate the delivery of approved technical source documents in accordance with project timelines.
Coordinate with Regulatory Operations to ensure timely and accurate submissions to Regulatory Authorities.
Support or manage interactions with regulatory authorities on MCC issues.
Provide regulatory support to other departments during Regulatory Authority inspections.
Serve as a Regulatory Affairs representative on facility/site Local Change Management Boards. Review and provide input on proposed health or regulatory authority guidance documents on MCC issues.
What the ideal candidate looks like:
3+ years of Medical Device regulatory experience.
Relevant 3rd level degree.
For a confidential discussion and more information on the role, please contact Aisling Lane.