|Job Ref No.:||1005|
|Job Title:||Regulatory Affairs Specialist|
|Experience Required||3-5 years relevant experience|
|Qualifications Required||Third level qualification in Science/Technical/Related Discipline|
Salary negotiable depending on experience
POSITION TITLE: Regulatory Affairs Specialist
Reporting to the RA Manager, the RA Specialist will be responsible for regulatory support for operations, product development and quality to ensure that the product is in compliance with all internal and external regulatory requirements. The RA Specialist will be a key member of the RA team. The role requires a high level of ownership and enthusiasm.
•Participates in product development/line extension teams as required to ensure that the product is in compliance with all internal and external regulatory requirements.
Develops, documents and implements a regulatory submissions plan around product development/line extension goals.
•Prepares U.S. FDA submissions (e.g., 510(k), IDE) as required and per applicable SOPs.
•Prepares and updates European and international technical files/dossiers/registrations as required and per applicable SOPs.
•Reviews Engineering Change Orders, Design Change Notices and other deviations for compliance with FDA, European and international regulations and standards.
•Assists Bard Corporate in updating establishment registrations and device listings as required.
•Ensures adequate documentation compliance to FDA, European and international regulations and standards. Ensures continuous update and maintenance of the Regulatory Affairs files.
•Develops working relationships with key personnel/representatives of the U.S. FDA Offices of Device Evaluation and Compliance and Notified Body.
•Understand and follow company procedures on regulatory requirements.
•Provide positive example and actively promote compliance to all standards.
•Maintain a professional working relationship with internal and external customer and support staff.
•Prepare and present project updates and technical discussions.
1. Third level technical/ Science qualification
2. Knowledge of U.S. and/or European and international regulations and standards covering medical devices.
3. Minimum of 2 years of RA related experience.
1. Excellent interpersonal skills with the ability to work in a team environment and work under own initiative to targets and deadlines.
2. Problem solving techniques with excellent organizational skills.
3. Dedication to excellence, flexibility and adaptability to change.
4. Attention to detail
6. Good teamwork capabilities, effective reporting
7. Fluent English communication skills (business English written and oral)