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:
- Experience with US and international regulations, and regulatory submissions preferred.
- Experience in writing/maintaining CE Technical Files preferred
- Experience in international medical device licensing preferred
- Excellent written and verbal communication skills, analytical skills and sound interpersonal skills
- Strong attention to detail and pride in accuracy
- Excellent proficiency in Microsoft Office (Word, Excel, Outlook, Power point)
- Exceptional organizing and prioritizing skills
- Ability to manage and track progress of project deliverables in order to meet deadlines and budgets
- Ability to influence people and functions
- A team player with positive can-do attitude
- A self-motivated and energetic person with an ability to work well under pressure
Education and Experience:
- Bachelor’s degree preferred.
- Two years of medical device, pharmaceutical, or other FDA-regulated industry experience required.
Physical Requirements:
- Ability and initiative to work in the following environments: ambiguous, fast paced, hands-on, and deadline dictated
- This position works in an open office environment or position can be performed remotely.
- While performing the duties of this Job, the employee is regularly required to talk or hear. The employee is frequently required to stand; walk and sit.
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.