Senior Regulatory Affairs Specialist

Senior Regulatory Affairs Specialist

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 Teleflex's Code of Ethics, all Company policies, rules, and procedures.

Education / Experience 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.

Specialized Skills / Other Requirements

At Teleflex, we follow a comprehensive hiring process. We do not accept unsolicited resumes from agency recruiters or 3rd party firms. We do not make unsolicited job offers. We do not ask for money or require equipment purchase up-front.

Teleflex Incorporated is an equal opportunity employer. Applicants will be considered without regard to age, race, religion, color, national origin, ancestry, sexual orientation, disability, nationality, sex, or veteran status. If you require accommodation to apply for a position, please contact us at : 877-880-8588 or Talent@Teleflex.com.

Teleflex, the Teleflex logo, Arrow, Barrigel, Deknatel, LMA, Pilling, QuikClot, Rsch, UroLift and Weck are trademarks or registered trademarks of Teleflex Incorporated or its affiliates, in the U.S. and / or other countries.

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