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Years of Experience
Date Last Verified
Senior Specialist, Regulatory Affairs The Candidate will be responsible to contribute to the development and implementation of the Regulatory Affairs groups policies and procedures. Represent regulatory affairs on various cross-functional business or product development teams to provide guidance and support including regulatory, design verification, and validation strategies to support all the regulatory aspects of the product development lifecycle. Use strategic regulatory concepts and company objectives, provide advice and counsel to resolve complex issues in creative and effective ways. Interface with cross functional departments to ensure proper coordination of regulatory strategy and timelines necessary to meet regulatory requirements. Assess regulatory impact of product changes on US and/or International regulatory strategy. Escalate reportability issues to management to ensure events are processed in accordance with regulatory requirements. Prepare and/or review technical documentation related to clinical performance, analytical performance and labelling. Edit complex and lengthy technical documents for clarity, grammar, spelling, punctuation and consistency. Participate in proactive and continuous improvements for Regulatory Affairs and in support of the quality system.
Qualification and Experience
The candidate should have Bachelor's degree in life science; an advanced degree is preferred (MS, MD, JD, PhD) with 5-7 years previous experience in regulated industry with a strong knowledge of global regulations and their interpretation relevant to OTC/DTC products. Expert level understanding of design control requirements. Problem solving skills and the ability to appropriately evaluate a situation and prioritize factors for fast decision making. Must have initiative, motivation, good judgement, ability to manage multiple tasks with frequent interruptions. Must be able to write clear, understandable technical regulatory documents. Ability to compile data and summarize results. Excellent ability to read, analyze and interpret technical documents, professional journals, technical procedures and government regulations. Tenacious attention to detail and consistency, especially with respect to grammar, usage, spelling, punctuation and style. Ability to prioritize and multi-task while maintaining a positive and collaborative attitude. Excellent communication and teamwork skills, and the ability to adapt and interface effectively with a wide range of stakeholders. Flexibility to support changing assignments and priorities in an independent and reliable manner.
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