Job Description
AT LIFENET HEALTH, YOU ARE THE ADVANTAGE Every day, you help us to save lives, restore health, and bring hope to patients and families around the world. At LifeNet Health, we cultivate growth, innovation, and collaboration, where your contributions drive solutions that benefit humanity. Together, we are united by a mission greater than ourselves, a purpose rooted in healing. About This Job Location: Virginia Beach, VA Department: Regulatory Affairs Schedule: Full-Time | Monday – Friday, 8:15am – 5:00pm Clinical Status: Non-Clinical How You’ll Make An Impact As the Vice President of Global Regulatory & Clinical Affairs you’ll play a vital role in advancing our mission. In this position, you’ll be responsible for strategic lead representing regulatory and clinical expertise while developing new approaches for business objectives. This role drives and enhances the operational effectiveness of the Regulatory and Clinical Affairs functions, including recommending solutions to reduce system complexities and inefficiencies. Combines knowledge of scientific, regulatory, clinical, medical and business issues to enable products that are developed, manufactured or distributed to meet required regulatory, compliance, and legislation. Plans, directs, coordinates and controls the Regulatory and Clinical Affairs activities related to products worldwide and serves as a change agent with the ability to influence at all levels of the organization. Your work will have purpose every single day, contributing directly to life-changing outcomes. What You’ll Do Regulatory and Clinical Affairs: Oversees development and implementation of regulatory and clinical strategies and provides guidance based on U.S. and International Laws and Regulations. 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 the entire organization, especially R&D, Quality systems, Manufacturing, and Sales and Marketing. Creates and develops product positioning strategies based upon regulatory requirements. Strategy/Administration: 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). Risk Management: Provides executive oversight of risk management policy and governance to ensure continued compliance with ISO 14971 and applicable regulatory expectations. Ensures risk management activities support product development, post‑market monitoring, regulatory submissions, and lifecycle decision making. Oversees integration of risk benefit considerations into regulatory strategies, clinical evaluations, and post‑market surveillance activities. Collaborates with cross functional leaders to ensure risk management outputs appropriately support regulatory submissions and responses. What You’ll Bring Minimum Requirements: Bachelor of Science: Engineering, Medical, Clinical or Biological Sciences Regulatory Affairs Certification: US, EU, and/or International TWELVE (12) Years – Personnel supervision with demonstrated leadership TEN (10) Years – Regulatory and Clinical Affairs experience in the medical devices or pharmaceutical industry with demonstrated increasing responsibility TEN (10) Years – Interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies FIVE (5) Years – Demonstrated success in US and International regulatory submission approvals, including IRBs, IDEs, PMAs, 510(k) Preferred Experience/Skills/Certifications Master’s Degree: Engineering, Medical, Clinical, or Biological Sciences FIFTEEN (15) Years – Personnel super