Senior Regulatory Affairs Specialist

Position Summary

The Sr. Regulatory Affairs Specialist (SRA) will develop US EU and Canada strategies assessments and submissions for complex projects across multiple business units and review issues related to regulatory documents investigations product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists as part of the role.

Principal Responsibilities

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 Teleflexs Code of Ethics all Company policies rules and procedures.

Education / Experience Requirements

Bachelors 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.

Specialized Skills / Other Requirements

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 BUs 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.

TRAVEL REQUIRED: 10%

The pay range for this position at commencement of employment is expected to be between $ 109300- $164000 however base pay offered may vary depending on multiple individualized factors including market location job-related knowledge skills and experience. The total compensation package for this position will also include benefits such as medical prescription drug dental and vision insurance flexible spending accounts participation in 401(k) savings plan and various paid time off benefits such as PTO short- and long-term disability and parental leave dependent on the position offered. Details of participation in these benefit plans will be provided if an employee receives an offer of employment.

If hired employee will be in an at-will position and the Company reserves the right to modify base salary (as well as any other discretionary payment or compensation program) at any time including for reasons related to individual performance Company or individual department/team performance and market factors.

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