A Major Medical Devices Company in Galway, Ireland wish to recruit a suitably qualified person for the following post:
SENIOR REGULATORY AFFAIRS SPECIALIST
SUMMARY OF DUTIES:
Based in the Galway office, the successful candidate will be responsible for coordinating, preparing, and maintaining regulatory submissions and documents for Australia and other countries. Primary responsibilities are to ensure regulatory compliance for assigned product lines. Other responsibilities include coordinating recalls, identifying relevant standards and guidance documents that affect Merit's business and products. In addition, assisting with TGA audits, Notified Body audits, and other regulatory agency/internal audits. Strong emphasis on European Medical device regulations/Australian Regulations for this position.
Determines regulatory pathways for various projects including product classification and subsequent regulatory submission to Regulatory agency/Distributor as required.
Construction of Technical Files and associated documentation and/ or regulatory rationales.
Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
Interacts with various levels of management, external agencies and companies.
Analyzes and makes recommendations regarding field complaints.
Remains current on developing regulations and revision of systems for continued compliance.
Participates in and assists with facility inspections, Notified Body Audits, TGA and other inspections/ audits as required.
Assists with supervision of department staff, as required.
Performs other related duties and tasks, as required.
Education and experience equivalent to a Bachelor's Degree in a technical field such as the biological, physical, engineering or material science disciplines and six years of related industry experience.
Demonstrated knowledge of the Medical Devices Directive (Preferable) (93/42/EEC, as amended), U.S. FDA regulations and various Quality System Standards/Regulations/Laws, including but not limited to ISO 13485, etc.
Demonstrated and verifiable experience with authoring regulatory submissions and interacting with reviewers.
Self-motivated, self-directing, strong attention to detail and excellent time management skills.
Strong interpersonal skills and the ability to communicate well -- verbally and in writing -- with others.
Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other
applicable software programs.
REMUNERATION: Excellent Salary/Benefits Package on offer and negotiable
Please forward CV immediately to:
For informal enquiries, please phone Christy O'Hara on 087-9473404 and if outside Ireland 00353 87 9473404