University president Jobs in Virginia Beach, VA

Vice President, Global Regulatory Affairs

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 :

• Regulatory Compliance : Oversees development and implementation of regulatory strategies and guidance based on . and International Laws and Regulations. Establishes effective dialogue with . 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 (., 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.
• 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.
• Strategic Planning & Implementation : Influences change with outside regulatory agencies and trade associations. Promotes LifeNet Health's positions to members of the . 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 : 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.
• Finance : Develops and manages Global Regulatory Affairs budget, assesses resource allocation, and develops annual work plans based on corporate strategy.

What you'll bring (Minimum Requirements) :

Preferred Experience / Skills / Certifications :

These would be nice too (Knowledge Skills and Abilities) :

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.

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