VP, Regulatory Affairs and Quality

Position Summary:

This individual will provide strategic direction for all Regulatory Affairs and Quality activities in support of global introduction and ongoing marketing of Nuvaira products and assure that Regulatory Affairs and Quality strategies and activities are developed, implemented and maintained, in support of corporate goals and objectives. Importantly, this individual will also be a member of Nuvaira’s executive committee and be expected to contribute as an executive leader during weekly meetings.

Responsibilities:

  • Establish and implement operating policies and procedures for Regulatory Affairs and Quality functions
  • Develop and communicate short and long term strategic and operating plans for Regulatory Affairs and Quality
  • Recruit and direct departmental human and capital resources to accomplish strategic and operating plans
  • Ensure that effective Regulatory Affairs and Quality strategies are developed and implemented for new and modified devices to assure timely FDA approval/market clearance, in support of corporate goals and objectives
  • Ensure compliance with relevant FDA regulations and guidelines, including 510(k), IDE, PMAA, GMP, MDR/vigilance and labeling/advertising
  • Ensure continuous compliance with quality system and other relevant regulations through a variety of quality assurance procedures
  • Provide oversight of and direction to the quality management systems in accordance with regulatory requirements, as well as key performance metrics to assure the maintenance of such systems
  • Demand high quality work from company departments that contribute to the achievement of company goals
  • Perform as Nuvaira’s lead liaison with governmental regulatory/quality/legal agencies
  • Present relevant materials at company board meetings as directed by the CEO
  • Work with the CEO to:
  • Provide input to the strategic planning process and future direction of the company
  • Support and participate in fundraising activities
  • Help drive the corporate timeline both within the Regulatory Affairs and Quality departments and cross functionally
  • Prepare annual operating budgets for the Regulatory Affairs and Quality departments and hold people accountable to stay within budget

 Qualifications:

  • Proven leadership skills and the ability to project self as a respected executive within the company
  • Ability to develop and execute long range strategies designed to achieve competitive advantage, and translate strategies into specific objectives and operational plans
  • Experience in successfully leading Quality and Regulatory teams in a commercial organization
  • Broad knowledge of US and OUS quality system requirements, OSHA and other applicable standards of compliance
  • Expertise in all aspects of product life cycle of medical devices with a track record of successful new product launches
  • In-depth knowledge of and demonstrated experience with leading cross-functional teams through development, implementation, application, and maintenance of Quality Systems which comply with FDA QSR, GMP, and related US and international regulations and ISO standards pertaining to IVD development and ongoing commercial manufacturing and delivery
  • Expert working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures (Including but not limited to FDA, PMAA, IDE, 510(k) Notifications, MDR, and Medical Device Directive)
  • Expert knowledge and understanding of company products and related U.S. medical device and international medical device regulations
  • Expert ability to negotiate critical points regarding devices with regulatory authorities
  • Knowledge and ability to review, modify, and approve technical literature as it relates to product specifications and compliance with domestic and international regulations
  • Excellent relationship building and persuasion skills with the ability to motivate and influence others; demonstrated record of overcoming resistance to change, and driving the adoption of new processes from a position of indirect or informal authority
  • Effective leadership and demonstrated ability to recruit, guide, mentor, and develop staff members and successors to key positions within the company
  • Excellent interpersonal and communication skills, including proven verbal, written, and presentation skills
  • Proven ability to cultivate an active network of relationships within and outside of the organization
  • Sound financial knowledge and experience to understand key financial indicators for the company and to evaluate strategic opportunities
  • Seasoned judgment to address and resolve critical issues and make timely, risk-based, and complex decisions
  • Detail-oriented with strong organizational skills and high quality standards
  • Self-motivated, hands-on critical thinker and problem solver, with the ability to lead by example, with an enthusiastic, optimistic outlook, and a collaborative style
  • Bachelor’s degree in the sciences; an advanced degree is preferred
  • Fifteen years of in depth experience in regulatory affairs, regulatory compliance, and quality systems in the medical device industry including:
  • Ten years in a strategic leadership position is required; or a combination of education and experience providing equivalent knowledge
  • Strong working knowledge of FDA, MDD and ISO regulations
  • Strong knowledge of clinical trial strategy, design and methods
  • Experience with interventional pulmonary devices desired, but not essential

 

 Physical Job Requirements:

The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job.  While performing the duties of this job, the employee is regularly required to be independently mobile.  The employee is also required to interact with a computer, and communicate with peers and co-workers.  Upon request, reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

 

This job description is intended as a summary of the primary responsibilities of and qualifications for this position. The job description is not intended as inclusive of all duties an individual in this position might be asked to perform or of all qualifications that may be required either now or in the future.

 

Nuvaira is an affirmative action, equal opportunity employer that values and actively seeks diversity in the workforce.