Senior Global Regulatory Affairs Specialist required by innovative medical devices multinational in West Dublin. You will prepare and project-manage high quality device registrations for approval by the US Food & Drug Administration and EU Competent Authorities.
Responsibilities:
- Functions under direction to address and implement tactical direction for device issues
- Effectively interacts with cross-functional project teams to meet project goals
- Works closely with devices RA team to achieve RA and business goals
- Under direction, performs activities to support assigned products to implement regulatory strategies to secure global device licenses and approvals
- Under direction, assembles the content of global regulatory dossiers
- Implements regulatory policy and strategy for assigned products
- Contributes to preparation and maintenance of risk assessment and mitigation strategy development for assigned products
- Implements plans for alignment of regulatory strategy and business objectives
- Investigates issues and prepares post-filing communications and deliverables
- Member of project team to deliver required regulatory contributions to meet business needs
- Remains abreast of modifications/variations in regulatory plans
- Works with manager to ensure regulatory strategy is developed for all key issues for assigned products
- Develops and expands knowledge of the regulatory environment in areas of commercial interest and its impact on regulatory strategy and implementation
- Under direction, prepare IDEs, 510(k)s, PMAs
- Participates in educational and business activities leading to basic knowledge of the therapeutic area
Requirements:
- Level 8 Science / Engineering Degree
- Excellent working knowledge of the USA and EU regulatory requirements and procedures
- Experience in the preparation of relevant technical, safety and performance technical documents to support submissions
- Quality control review of technical/ regulatory documents
- Understanding of Regulatory strategy and determination of documentation requirements, timelines, budgets and filing options
- Compliance with SOPs, Change controls and regulatory best practices
- Familiarity with electronic submissions (eCTD) useful
- Familiar with MS Office, or equivalent, etc.
- Excellent written and oral communication skills required
- Attention to detail and ability to handle multi-faceted projects at the same time a distinct advantage
- Project management experience – an advantage
- Hardworking, self-motivated and with attention to detail
Please contact Emer Smith to discuss in confidence
00353578638188
emer@emtechrecruitment.ie
