I want to keep my account, but I don’t want people to see my CV
Click ‘PRIVACY SETTINGS’, then select ‘I don't wish to be contacted about jobs by companies looking to hire'
I want to keep my account, but I don’t want to receive jobs by email
Click ‘JOBS BY EMAIL’ then choose ‘REMOVE THIS JOB ALERT EMAIL’ next to any of your alerts.
I want to permanently remove my account from this site
This will permanently remove all of your details and CV from our site. If you want to apply for any jobs in the future, you can apply as a guest or you will have re-register.
A Major Medical Devices Company in Galway City, Ireland is seeking to recruit a suitably qualified person for the following post:
PRINCIPAL REGULATORY AFFAIRS SPECIALIST
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 Company's 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.
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.
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.
REMUNERATION: Excellent Salary/Benefits Package on offer and negotiable
Please forward CV immediately to:
For informal enquiries, please phone Christy O'Hara on Applyand if outside Ireland Apply
Ref: NET - 173984