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Years of Experience
Date Last Verified
Regulatory Affairs Project Manager, Immunoassays Duties: Responsible for implementing and maintaining the effectiveness of the quality system. Responsible for compliance with applicable Corporate and Divisional Policies and procedures. Develop new regulatory policies; processes and SOPs and train key personnel on them. Evaluate regulatory risks of division policies; processes; procedures. Provide regulatory input to product lifecycle planning. Monitor regulatory outcomes of initial product concepts and provide input to senior regulatory management. Assist in the development of multi country regulatory strategy and update strategy based upon regulatory changes. Assist in regulatory due diligence for potential and new acquisitions. Utilize technical regulatory skills to propose strategies on complex issues. Determine submission and approval requirements. Identify emerging issues. Monitor trade association positions for impact on company products. Anticipate regulatory obstacles and emerging issues throughout the product lifecycle and develop solutions with other members of regulatory and related teams. Recruit; develop and mentor regulatory professionals. Assess the acceptability of quality; preclinical and clinical documentation for submission filing. Evaluate risk of and regulatory solutions to product and clinical safety issues during clinical phases and recommend solutions. Compile; prepare; review and submit regulatory submission to authorities. Monitor impact of changing regulations on submission strategies and update internal stakeholders. Monitor applications under regulatory review. Communicate application progress to internal stakeholders. Monitor and submit applicable reports and ensure appropriate responses are submitted to regulatory authorities. Evaluate proposed preclinical; clinical and manufacturing changes for regulatory filing strategies. Negotiate and interact with regulatory authorities during the development and review process to ensure submission approval. Provide strategic input and technical guidance on regulatory requirements to development teams. Manage and execute preapproval compliance activities. Oversee processes involved with maintaining annual licenses; registrations; listings and patent information. Ensure compliance with product post marketing approval requirements. Review and approve advertising and promotional items to ensure regulatory compliance. Ensure external communications meet regulations. Develop; implement and manage appropriate SOPs and systems to track and manage product-associated events. Actively contribute to the development and functioning of the crisis/issue management program. Oversee system to ensure that product safety issues and product-associated events are reported to regulatory agencies. Report adverse events to regulatory agencies and internal stakeholders. Provide regulatory input for product recalls and recall communications.
Qualification and Experience
Qualifications: Bachelor’s degree (or equivalent); Bachelor’s degree in science (biology; chemistry; microbiology; immunology; medical technology; pharmacy; pharmacology); math; engineering; or medical fields is preferred. M.S. in a technical area or M.B.A. is preferred. A Ph.D. in a technical area or law is helpful. Certification is a plus (such as RAC from the Regulatory Affairs Professionals Society.) 2-5 years of experience in regulatory preferred but may consider quality assurance, research and development/support, scientific affairs, operations, or related area. 4-5 years experience in a regulated industry (e.g., medical products, nutritionals). Preferred: M.S. in Regulatory Affairs/Regulatory Science is preferred 5+ years of experience in IVD assay development and/or regulatory 2-5 years of experience with IVD submissions/registrations (US and/or International).
JOB ID: 30059734
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