Excellent Senior Regulatory Specialist role available in Cork. Great opportunity to join a leading medical device company. This role can be fully remote or based onsite
As a Senior Regulatory Affairs Specialist the key function of this position is to lead regulatory strategies for the Cork site projects and for local continuous improvement initiatives.
Prepare and support regulatory submissions related to the company's range of medical devices. To be a key member of the Regulatory Affairs group and to demonstrate flexibility as priorities change Maintain site Regulatory Affairs compliance, based on cGMP per requirements as defined in FDA 21CFR820, ISO 13485, MDR, CMDCAS, and other International Regulations.
Key member of the New Product Introduction projects to ensure alignment with corporate commercialization strategies for Tier 1, 2 and 3 ROW markets.
Lead Product Support member of LCM projects to ensure documented continued device compliance to applicable market regulatory requirements.
Review and approve (as necessary) product labelling materials for compliance with applicable regulations and standards.
Participate in internal and external company regulatory /quality audits
Lead RA representative for site change management with input into RA metric reporting
Maintain currency and accuracy of CE Technical Files aligned with device and process changes
Prepare regulatory dossiers for submission to Health Authorities and maintain them along the whole product life-cycle
Support proactive engagement with Division and key stakeholders
Lead preparation of regulatory submissions to FDA 510(k), PMA supplements and dossiers for other International Regulatory agencies.
Monitor global market regulatory changes, advise and/ or implement changes to ensure compliance.
Involvement in the general activities within the department, including improving and implementing integrated regulatory business processes.
Interpret new Medical Device Regulations and develop internal procedures to ensure continuous compliance with all regulatory requirements
Ensure continual Quality System compliance by adherence to established and evolving QS requirements.
Specific Position knowledge/skills/abilities:
Flexible with the ability to adjust to changes in schedule, priorities
Must be articulate and able to communicate effectively with associates at all levels of the organization
Demonstrated strong attention to detail
Excellent time management skills and proven ability to meet tight deadlines and ability to work under pressure
Thrive in a fast-paced work environment, while possessing the ability to quickly change priorities and perform multiple tasks simultaneously
Pro-active with proven ability to work under own initiative, problem solve and be a strong team player
Ability to work on diverse project teams to provide Regulatory expertise and leadership.
Proven track record in writing Regulatory medical device submissions
Morgan McKinley is acting as an Employment Agency and references to pay rates are indicative.