Senior Regulatory Affairs Specialist
Teleflex
full-time
Posted on:
Location Type: Office
Location: Maple Grove • Minnesota • United States
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Salary
💰 $109,300 - $164,000 per year
Job Level
About the role
- Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the US, EU and Canada for new and modified products.
- Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments.
- Communicate with Commercial RA to ensure timely notification of changes as appropriate. Partner with Commercial RA to support registration of product in foreign markets.
- Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.
- Interact and negotiate with regulatory authorities during the development (i.e. Q-Sub, change notifications, etc.) and submission review.
- Support regulatory agency and/or notified body audits by as needed.
- Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.
- Participate in development and approval of risk activities as well as other deliverables as related to projects.
- Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.).
- Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated.
- Assist in regulatory due diligence process as needed.
- Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.
- Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.
- Brings Regulatory Affairs questions/issues to the attention of RA management.
- Comply with Teleflex’s Code of Ethics, all Company policies, rules, and procedures.
Requirements
- Bachelor’s degree in a science or engineering field, or equivalent work experience.
- 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of experience with Class I, II or III medical devices.
- Proven history of successful domestic and/or international submissions.
- Strong analytical and critical thinking skills.
- Strong verbal and writing communication skills.
- Ability to manage and prioritize multiple projects to meet deadlines that align with the BU’s objectives.
- Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.
- Proficiency in MS Office software programs
- RAC certification is a plus.
Benefits
- medical, prescription drug, dental and vision insurance
- flexible spending accounts
- participation in 401(k) savings plan
- paid time off benefits, such as PTO, short- and long-term disability and parental leave
Applicant Tracking System Keywords
Tip: use these terms in your resume and cover letter to boost ATS matches.
Hard skills
regulatory assessments510(k) premarket notificationsEU MDD Technical FileMDR Technical DocumentationCanadian license submissiondesign controlsrisk activitiespost-market surveillancelabeling reviewregulatory due diligence
Soft skills
analytical skillscritical thinkingverbal communicationwriting communicationproject managementprioritizationcollaborationteam player
Certifications
RAC certification