LifeNet Health

LifeNet Health, headquartered in Virginia Beach, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine.. Our goal is to improve the quality of human life through the provisions of organs, tissues and cells for transplantation; to provide innovation in the field of bio-implants, regenerative medicine and research; and to serve the community with educational and support services that enhance the donation process.. Finance: Develops and manages Global Regulatory Affairs budget, assesses resource allocation, and develops annual work plans based on corporate strategy.. Ten (10) years Regulatory Affairs and Quality experience in the medical devices or pharmaceutical industry with increasing responsibility (including experience interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies). Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies)

regulatory affairs

Description Vice President, Global Regulatory Affairs & Quality Assurance Location: Virginia Beach, VA (Concert Drive) Department: Regulatory Affairs Job Type: Full-Time Shift: Mon-Fri 5:45AM-2:30PM Clinical Classification: Non-Clinical LifeNet Health is searching for talented individuals who will embrace our mission of saving lives, restoring health, and giving hope. LifeNet Health, headquartered in Virginia Beach, is the largest nonprofit organ procurement organization ("OPO") and tissue processor in the United States, as well as a leading innovator in tissue engineering and regenerative medicine. Our goal is to improve the quality of human life through the provisions of organs, tissues and cells for transplantation; to provide innovation in the field of bio-implants, regenerative medicine and research; and to serve the community with educational and support services that enhance the donation process. LifeNet Health has over 1200 employees and has a growing global presence. How you will contribute to LifeNet Health's success: As the VP, Global Regulatory Affairs (GRA) & Quality Assurance you are the strategic lead representing regulatory affairs expertise while developing new approaches for business objectives. This role understands regulated quality systems, FDA regulations, international ISO standards, and people leadership. The role drives and enhances the operational effectiveness of the Regulatory function, including recommending solutions to reduce system complexities and inefficiencies. Combines knowledge of scientific, regulatory, medical, and business issues to enable products that are developed, manufactured, or distributed to meet required regulatory/compliance/legislation. Plans, directs, coordinates, and controls the Regulatory Affairs activities related to products worldwide. Acts as a Change Agent with the ability to influence at all levels of the organization. What you'll do: <ul><li>Regulatory Compliance: Oversees development and implementation of regulatory strategies and guidance based on U.S. and International Laws and Regulations. Establishes effective dialogue with U.S. and International regulatory authorities. Represents the regulatory aspects of product associated events, recalls and product withdrawals. Leads efforts to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g., orphan, conditional approval, breakthrough therapy) or for complex and/or critical products. Analyzes and compares regulatory outcomes with initial product concepts and recommends future strategies and actions. Provides recommendations to decision makers on regulatory strategies and options on new products or claims that balance business needs with regulatory oversight. Provides regulatory guidance to entire organization, especially R&D, Quality systems, Manufacturing, and Sales and Marketing. Creates and develops product positioning strategies based upon regulatory requirements.</li><li>People Leadership: Provides oversight to assigned team by supervising, guiding, and directing employees to be effective team members. Ensures that everyone is equipped with the right skills, tools, and talents necessary for executing their duties. Using the established people processes (performance, development, succession, and career) to ensure that their team's level of performance and capabilities meet current and future standards.</li><li>Strategic Planning & Implementation: Influences change with outside regulatory agencies and trade associations. Promotes LifeNet Health's positions to members of the U.S. Congress to ensure appropriate oversight into agency regulations. Acts as liaison with appropriate local, national, and international regulatory authorities. Develops and advances the organization's policy and procedures for regulatory affairs to establish a strategic and compliant culture. Identifies and monitors need for new regulatory affairs policies, processes, and resources. Develops the organization's national, regional, and global regulatory position(s) and strategy based upon assessment and synthesis of internal and external intelligence (opportunities/risks).</li><li>Risk Management: Anticipates regulatory and related obstacles and emerging issues throughout the product lifecycle. Provides executive management with updates on the current and changing regulatory environment and its impact on LifeNet Health. Communicates appropriate metrics on GRA performance. Conducts Due Diligence with respect to regulatory affairs as requested and approves regulatory provisions of partnership agreements. Provides recommendations on project decisions and makes recommendations for Improvements. Develops corporate positions on regulatory risk-benefit. Develops solutions with other members of the ELT, management, and stakeholders to address issues.</li><li>Finance: Develops and manages Global Regulatory Affairs budget, assesses resource allocation, and develops annual work plans based on corporate strategy.</li></ul> What you'll bring (Minimum Requirements): <ul><li>Bachelor of Science</li><li>Regulatory Affairs Certification (RAC) US, EU, and/or International from RAPS </li><li>Ten (10) years Regulatory Affairs and Quality experience in the medical devices or pharmaceutical industry with increasing responsibility (including experience interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies)</li><li>Eight (8) years of direct people leadership experience</li><li>Five (5) years of demonstrated success in US Regulatory submission approvals, including IRBs, IDE's, PMA's, 510(k)s</li></ul> Preferred Experience/Skills/Certifications: <ul><li>Master's Degree</li><li>Fifteen (15) years of experience in Regulatory Affairs and Quality experience in the biotechnology, medical devices, or pharmaceutical industry with increasing responsibility (including interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies)</li><li>Ten (10) years of demonstrated success in US and international regulatory submission approvals, including IRBs, IDE's, PMA's, 510(k)s</li></ul> These would be nice too (Knowledge Skills and Abilities): <ul><li>Knowledge of Major Markets' regulatory laws, policies, regulations, and guidelines </li></ul><ul><li>Mechanism of action, specifications, standards and history, medical applications, development, processing and manufacturing of medical devices, biologics, or pharmaceuticals</li></ul><ul><li>Actively leads and engages in policy development, implementation, and communication by framing emerging issues and contributing expertise in support of the organization's vision, strategy, priorities, and obligations. Exhibits above average emotional intelligence.</li></ul><ul><li>Leads thorough analysis of situations with appropriate attention to details and the big picture including consideration of impact at multiple levels of the system.</li><li>Makes timely and effective decisions, balancing the need for more information or analysis with the need to be decisive. Makes tough or unpopular decisions where mission outcomes supersede the interests/concerns of individuals, constituencies, or current situation.</li><li>Builds and sustains partnership across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes</li><li>Actively engages in talent management practices (selection, promotion, development and engagement) to cultivate a workforce that is well aligned with current and emerging talent needs</li><li>Strategic planning and interfacing throughout the product lifecycle especially for complex or critical products. Impact of regulatory changes on internal processes and products</li><li>Able to navigate ambiguity, demonstrate agility, and those characteristics expected of executive-level individuals. They must possess and communicate a strong understanding of the requirements, opportunities, risks and alternatives for developing and maintaining products</li></ul> Why work at LifeNet Health? We have a fierce drive for our mission of Saving Lives, Restoring Health, and Giving Hope. You won't find another company with a culture as strong as ours. <ul><li>403(b) and Profit-Sharing Plan</li><li>Affordable medical, dental, and vision coverage</li><li>Corporate-sponsored events </li><li>Work-life balance with generous paid time off to include vacation time, sick time, and paid holidays. </li><li>Tuition reimbursement</li><li>Personal career, skill, and leadership development opportunities</li><li>Wellness Program (gym reimbursement, monthly wellness webinars, mental health toolkit, financial resources, and much more)</li><li>Employee Assistance Program (EAP) to include employees and their family members.</li><li>Dedicated and passionate co-workers</li></ul> *The pay rate for the successful candidate will depend on geographic location and the candidate's qualifications including prior relevant experience. The pay range for this position is $197,760 annually (entry-level qualifications) to $263,680 annually (experienced in this role). *Actual compensation may be higher based on the successful candidate's knowledge and relevant experience. *This position is also eligible for an annual bonus based on certain criteria being met. "All benefits are subject to eligibility requirements and LifeNet Health reserves the right to modify or change these benefits programs at any time, with or without notice, unless otherwise required by law. Further, nothing in this posting is intended to alter the "at will" relationship of a successful candidate and this posting does not constitute a specific promise." We are proud to be an EEO/AA employer EOE/M/F/Disability/Vet. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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