Senior Regulatory Affairs Specialist
Our client, a medical device company in Galway are currently looking to recruit a Senior Regulatory Affairs Specialist for their site on a contract basis.
Summary of Duties:
Responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, 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 the business and products, assisting with FDA facility inspections, Notified Body audits, and other internal audits.
- Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements of U.S. and international submissions, Technical Files or regulatory rationales.
- Identifies guidance documents, international standards, Consensus Standards and assists teams with their interpretation.
- Prepares regulatory submissions to the FDA, the Notified Body and other regulatory authorities and /or Distributors.
- Prepares IDEs and PMAs and assists with clinical trials when required.
- Interacts with various levels of management, external agencies and companies.
- Analyses and makes recommendations regarding field complaints.
- Develops, maintains and analyses department systems and provides training when needed.
- Remains current on developing regulations and revises systems.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other inspections and audits as required.
- Assists with supervision of department staff, as required.
- Performs other related duties and tasks, as required.
Summary of Minimum Qualifications:
- 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 U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), 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.
For further information on this Senior Regulatory Affairs Specialist role in Galway please contact Bimi Felix on 091730022 / email@example.com
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