Vice President, Global Regulatory Affairs & Quality Assurance
Company: LifeNet Health
Location: Virginia Beach
Posted on: September 17, 2024
Job Description:
Vice President, Global Regulatory AffairsLocation: Virginia
Beach, VA (Concert Drive)Department: Regulatory AffairsJob Type:
Full-TimeShift: Mon-Fri 5:45AM-2:30PMClinical Classification:
Non-ClinicalLifeNet 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 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. 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 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: 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):
- Bachelor of Science
- 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)
- Eight (8) years of direct people leadership experience
- Five (5) years of demonstrated success in US Regulatory
submission approvals, including IRBs, IDE's, PMA's,
510(k)sPreferred Experience/Skills/Certifications:
- Master's Degree
- Regulatory Affairs Certification (RAC) US, EU, and/or
International from RAPS
- 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)
- Ten (10) years of demonstrated success in US and international
regulatory submission approvals, including IRBs, IDE's, PMA's,
510(k)sThese would be nice too (Knowledge Skills and Abilities):
- Knowledge of Major Markets' regulatory laws, policies,
regulations, and guidelines
- Mechanism of action, specifications, standards and history,
medical applications, development, processing and manufacturing of
medical devices, biologics, or pharmaceuticals
- 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.
- Leads thorough analysis of situations with appropriate
attention to details and the big picture including consideration of
impact at multiple levels of the system.
- 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.
- Builds and sustains partnership across organizational
boundaries and functions as well as outside the organization to
achieve common goals and outcomes
- 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 planning and interfacing throughout the product
lifecycle especially for complex or critical products. Impact of
regulatory changes on internal processes and products
- 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 productsWhy 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.
- 403(b) and Profit-Sharing Plan
- Affordable medical, dental, and vision coverage
- Corporate-sponsored events
- Work-life balance with generous paid time off to include
vacation time, sick time, and paid holidays.
- Tuition reimbursement
- Personal career, skill, and leadership development
opportunities
- Wellness Program (gym reimbursement, monthly wellness webinars,
mental health toolkit, financial resources, and much more)
- Employee Assistance Program (EAP) to include employees and
their family members.
- Dedicated and passionate co-workers*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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Keywords: LifeNet Health, Virginia Beach , Vice President, Global Regulatory Affairs & Quality Assurance, Executive , Virginia Beach, Virginia
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