Reg Affairs Specialist
I am delighted to be working with this well known med device company based in Cork. My client is hiring for a Regulatory Affairs Specialist position to join their top class team. This really is an excellent role and will open lots of doors for the right candidate.
Your role will be to Manage Regulatory Affairs for the site. Responsible for all regulatory submissions at the site and Product Registrations, ensuring compliance with GMP, ISO and applicable Regulatory requirements.
Review and perform regulatory assessments for product and process change controls for potential impact on current Regulatory filings.
Prepare regulatory strategies and participate in the preparation of the quality documentation to support registration dossier applications and variation applications in global markets
Participate in and provide regulatory support to project teams for development, continuous improvement and life-cycle management of the products.
Support the management of global regulatory submissions and updates according to company strategy and ensure meeting registration deadlines
Support the coordination and establishment of product labelling changes from a global regulatory perspective
Support regulatory inspections including management of facility preparadeness.
Be involved in the general activities wihin the department, including improving and implementing integrated regulatory business processes.
Build departmental awareness of local regulatory requirements in global markets
Ensure facility documentation compliance to FDA QSRs, ISO 13485 and QS Standards.
Ensure continual Quality System compliance by adherence to established and evolving QS requirements.
- BSc in Science or related qualification
- 2/3 years regulatory experience
To find out more about this role, please apply below, or connect with me, Julieann Fitzpatrick, on linked in. I'm always happy to help.
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.
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