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S/VP Regulatory and Quality

Direct the activities of the World Wide Regulatory and Quality departments, with specific focus on U.S. and European regions.  Assure Compliance with all applicable laws, standards and guidances, within the highly regulated bio-pharmaceutical industry, to ensure that the Company’s products meet regulatory requirements and quality standards.  Represent us to the Health Authorities globally, to present and defend our products and standards both through regulatory submissions, meetings and audits for both licensed and unlicensed products.

Primary Responsibilities:

  • Oversee the Regulatory Affairs and Quality Departments worldwide.  Assume overall responsibility and liability for performance against results.  Motivate employees to fulfill their obligations and inspire them to achieve results.  Has the managerial courage to establish consequences when necessary.
  • Knowledge of International regulations, ISO standards, QMS, MDD and MDR requirements in Europe, knowledge of key European countries regarding biologics and combination products, knowledge of 21 CFR 4, 200, 300, 600, 800.
  • Ability to deal with ambiguity given the nature of our products which are defined differently in the world wide regulatory environment; products represent a device, biologic, a drug/device combination product depending on the regulatory requirements within a specific country.
  • Interact with management and external agencies to define and develop broad regulatory strategies consistent with business objectives and regulatory requirements with particular emphasis on blood policy in the US and Internationally.  Able to promote and represent pathogen inactivation as the standard of care for blood transfusion safety
  • Assure Sr Management Team and Board of Directors have appropriate knowledge of risks and performance of our products both licensed and unlicensed.
  • Manage all external suppliers of raw materials and products, using a complex matrix of external manufacturing contracts, to maintain compliance with our standards and meet the demands of the Commercial and Clinical need for products.
  • Maintain a high profile interface with associations and external groups to increase our influence and ability to take advantage of a changing regulatory environment.
  • Represent us externally in discussions with regulatory authorities worldwide with emphasis on the U.S., Europe, Canada and Asia especially Japan and China.
  • Perform the duties of our Quality Management Representative meeting the formal European definition in compliance with the roles and responsibilities of that position.
  • Provide insight into the potential regulatory risks and benefits of our business plans, including directing alternative action plans based on risk/benefit analyses.
  • Develop and implement regulatory strategies aimed at gaining the earliest possible regulatory approvals as well as the tactical execution of all regulatory submissions and filings.
  • Develop regulatory strategies, systems and processes to ensure that our development, registration and commercialization plans meet all federal, foreign, and company requirements to enable the effective advancement of products from design concept through marketing, and post market surveillance.
  • Interact with executive team on a peer basis as part of the Senior Management team.
  • Oversee and participate in the writing, review, editing and compilation of regulatory submissions and quality documentation.
  • Ensure compliance to federal and international regulations and standards related to drug and device development and commercialization.
  • Develop and implement quality management system processes to ensure the system effectively meets the objectives of the corporate quality policy.
  • Assure that we maintain the appropriate Compliance policies and standards.
  • Assure completion of departmental tasks and projects and actively gather staff feedback and perspective.  Establish policies and procedures based on accepted principles, and ensure adherence to these policies and procedures.
  • Manage and participate in human resources/organizational development activities including; recruitment of key regulatory and quality personnel, performance management, employee development and training as well as career development opportunities within the departments.
  • Ensure budgets and schedules are met.
  • Perform other related duties as required.


  • Master’s degree or Ph.D. (preferred) in related field or equivalent related experience.
  • Minimum 18 years regulatory and clinical experience; includes quality management experience or equivalent combination of education and relevant regulatory experience; includes 10 years management background.
  • Highly desirable to have a network of connections, with peers and health authority personnel, to have a proven track record of credibility in the regulatory and quality circles.
  • Thorough understanding of U.S. and International regulatory requirements and standards for development, clinical testing, manufacture, marketing, and distribution of either medical devices or biologics, preferably experience with both.
  • Experience in all phases of product commercialization, including product development, product approvals and post-approval.
  • Demonstrated ability to work with external manufacturing and supply partners to assure that our  goals are achieved while maintaining a collaborative long term partnership.
  • Demonstrated ability to interact successfully with regulatory agencies, including in a strategic role.
  • Ability to integrate regulatory expertise with our business objectives; strong sense of Company with ability to translate corporate goals into project plan.
  • Subscribes to and models our management expectations.
  • Recognized as an effective leader; strong leadership, management and mentoring skills; team oriented.
  • Ability to effectively communicate, coordinate and interact with upper management, managers and personnel within other departments (encompasses verbal, written, interpersonal, listening); interpersonal skills and ability to communicate across multiple disciplines successfully and accurately (internally and externally, e.g., FDA and international regulatory authorities).
  • Strong negotiation skills.
  • Time Management (timelines, schedules, task prioritization).
  • Attention to detail and accuracy.
  • Flexible; ability to adapt to changing priorities.
  • Able to fully understand scientific, medical and manufacturing disciplines.
  • Ability to manage and motivate highly trained personnel, in both the Quality and Regulatory departments, to minimize turnover and provide opportunities for independent performance and growth.

qualified candidates should email CV and Cover Letter to