Vice President, Global Regulatory & Clinical Affairs

LifeNet Health•Virginia Beach, VA

About The Position

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.

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)

Nice To Haves

Master’s Degree: Engineering, Medical, Clinical, or Biological Sciences
FIFTEEN (15) Years – Personnel supervision with demonstrated leadership
FIFTEEN (15) Years – Regulatory and Clinical Affairs experience in the medical devices or pharmaceutical industry with demonstrated increasing responsibility
FIFTEEN (15) Years – Interfacing with FDA and other regulatory agencies in development and commercialization of new medical technologies
TEN (1) Years – Demonstrated success in US and International regulatory submission approvals, including IRBs, IDEs, PMAs, 510(k)
Knowledge of Major Markets’ regulatory laws, policies, regulations and guidelines: US, Canada, EEA medical device and/or drugs laws, regulations, directives and guidance for device or drug approval/registration and manufacturer registration requirements, all product classes.
Product Knowledge : Mechanism of action, specifications, standards and history, medical applications, development, processing and manufacturing of medical devices, biologics or pharmaceuticals.
Leadership: Actively leads and engages direct reports and overall team in development, implementation and communication by framing emerging issues and contributing expertise in support of the organization’s vision, strategy, priorities and obligations.
Research/Problem Solving: Leads thorough analysis of situations with appropriate attention to detail and the big picture including consideration of impact at multiple levels of the system.
Regulatory approval: Leads thorough analysis of situations with appropriate attention to detail and the big picture including consideration of impact at multiple levels of the system.
Decision Making: 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.
Relationships: Builds and sustains partnership across organizational boundaries and functions as well as outside the organization to achieve common goals and outcomes
People Development: 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.
Strategic thinking: Strategic planning and interfacing throughout the product lifecycle especially for complex or critical products. Impact of regulatory changes on internal processes and products.
Problem Solving/Crisis Management: 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.

Responsibilities

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.

Benefits

Affordable Medical, Dental, and Vision Coverage - Comprehensive care that won’t break the bank.
Profit Sharing Plan - Share in the success you help create.
403(b) Retirement Plan - Invest in your future with confidence.
Paid Parental Leave - 6 weeks to bond with your newest family member.
Corporate Sponsored Events - Celebrate milestones and build connections.
Generous Paid Time Off - Because balance matters: 18 vacation days (based on position, tenure, and state laws) 9 sick days (subject to local and state regulations) 9 holidays (7 standard + 2 floating)
Flexible Work Program - For approved roles, how and where you perform best.
Tuition reimbursement - We invest in your growth and education.
Career & Leadership Development - Expand your impact and potential.
Wellness Program - Prioritize your health with holistic resources.
Employee Assistance Program (EAP) - Support for you and your household.
Incredible teammates - Collaborate with passionate, dedicated professionals.