Regulatory Affairs Specialist

Job Description

Job Description

The following is intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required.

Job Summary :

The Regulatory Affairs Specialist is responsible for supporting Regulatory activities which lead to, and maintain, regulatory compliance and approval for TriMed products globally.

Supervisory Responsibilities :

None.

Duties / Responsibilities :

• Perform gap analyses between new / revised regulations and standards and the TriMed Quality Management System (QMS).
• Review and assess published literature, preclinical data, clinical investigation results, field performance data and other relevant post-market surveillance data in order to evaluate device safety and performance.
• Compile Clinical Evaluation Plans and Reports.
• Assess reportability of changes to : labeling, design, materials, manufacturing process, sterilization or packaging.
• Working with other departments, gather data for completing Post-Market Surveillance Reports, Periodic Safety Update Reports, Critical Analysis Reports, Summary of Safety and Performance Reports, etc.
• Compile needed post-market reports.
• Facilitate the completion of actions identified as a result of post-market reports.
• Compile necessary documentation for the creation of technical files. Maintain technical files.
• Assist with writing submission documents for regulatory agencies (FDA, Health Canada, etc.) and Notified Bodies.
• Develop responses to questions or deficiency letters from regulatory agencies and notified bodies.
• Use technical / clinical writing skills to clearly describe technical information for third party reviewers.
• Perform submissions using the regulatory agency’s electronic submission process, if applicable (ESG, EUDAMED, etc.).
• Maintain registrations, certifications, and / or licenses, as applicable.
• Assist new product development teams to provide regulatory support to the project
• Develop positive working relationships with other departments.
• Actively participate in third party audits of TriMed.

Required Skills / Abilities :

Education and Experience :

Physical Requirements :

TriMed, Inc. is an Equal Employment Opportunity Employer and does not discriminate against applicants or employees on the basis of race, color, religion, creed, national origin, ancestry, disability that can be reasonably accommodated without undue hardship, sex, sexual orientation, gender identity, age, citizenship, marital or veteran status, or any other legally protected status.