Life Science Recruitment are sourcing a Senior Regulatory Affairs Specialist for our client who are a global medical device company. This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries.
Roles & Responsibilities
• 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.
• Analyzes and makes recommendations regarding field complaints.
• Develops, maintains and analyzes 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.
Skills & 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.
If you would like further Information you can contact the recruiter directly:
Simon Gillivan | Tel: +353 (0) 1 507 9258
PLEASE APPLY DIRECTLY BY CLICKING HERE
Under the Data Protection Acts 1988 and 2003, your details will be kept confidential and will not be passed to a third party without your express prior consent.
Science Recruitment | Engineering Jobs | Scientific Jobs
Pharmaceutical Jobs | Medical Device Jobs | Clinical Research Jobs | Biotechnology Jobs