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Sr. Regulatory Affairs Specialist

Integrate regulatory knowledge throughout the product lifecycle with aspects of effective project management and strategy. Support the Regulatory Affairs function by assisting the coordination and preparation of global regulatory premarket submissions. Participate on multidisciplinary teams and communicate regulatory requirements effectively. Conduct appropriate research to develop strong regulatory strategies for new products. Determine issues which may create regulatory obstacles and investigate solutions to address these issues. Negotiate and interact with regulatory authorities like FDA, Notified bodies etc., during the development and review process to ensure submission approval. Oversee the organization and preparation of regulatory submissions and all applicable documentation. Participate in Risk Management assessments. Evaluate regulatory impact of proposed design and manufacturing changes. Review and approve all Labeling (product, advertising and promotional). Assist in regulatory due diligence process. Assist in departmental SOP development and implementation. Assist in Clinical Evaluation and Post market surveillance updates. Monitor impact of changing evolving global regulations and standards on submissions, practices and procedures and communicate to internal stakeholders. Assist with environmental regulations and standards (RoHS, etc.).
Requires MS degree in science, pharmacy, engineering, regulatory affairs or related field plus 36 months of experience in medical device regulatory affairs (or BS degree plus 60 months). Also requires: ability to apply business and Regulatory Affairs ethical standards; excellent analytical and critical thinking skills; strong verbal and writing communication skills; demonstrated leadership skills; ability to manage multiple projects and meet deadlines; and proficiency in Word, Excel, Power Point, and Outlook. Requires up to 10% domestic and international travel. To apply, visit teleflex.com/careers.

Equal Opportunity Employer Minorities/Women/Protected Veterans/Disabled
 




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