Regulatory Affairs Specialist (Fixed Term Contract)
This position is responsible for coordinating, preparing, and maintaining regulatory submissions and documents on a global level. Primary responsibilities are to ensure regulatory compliance for assigned product lines as Merit evolves. Other responsibilities include supporting recalls, identifying relevant standards and guidance documents that affect Merit’s business and products, assisting with Governmental facility inspections, Notified Body audits and conducting internal audits when directed.
- Assist with the determination of regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.
- Participates on various teams to define regulatory requirements for EU, US and Canadian submissions.
- Identifies guidance documents, international standards, consensus standards and assists teams with their interpretation.
- Prepares regulatory submissions to regulatory authorities.
- Interacts with various levels of management, external agencies and companies.
- Assist with developing, maintaining and analysing department systems and provides training when needed.
- Remains current on developing regulations and revises systems as necessary.
- Participates in and assists with FDA facility inspections, Notified Body Audits and other governmental inspections as directed.
- Performs other related duties and tasks, as required.
- Education and experience equivalent to a Bachelor’s Degree in the biological, physical, engineering or material science disciplines and four years of related experience.
- Knowledge of U.S. FDA regulations, the Medical Devices Directive (93/42/EEC, as amended), and ISO 13485 Quality System Standards.
- 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.
Merit Medical is an Equal Opportunities Employer
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