Vice President Quality Regulatory Affairs
Reporting into the Chief Executive Officer, the Vice President of Quality and Regulatory Affairs is responsible for developing, coordinating, and implementing quality and regulatory strategies and quality programs required for the development, regulatory approval, successful manufacture, commercialization, and post-market surveillance of its products.
Responsible for interacting, influencing, and collaborating with all levels of the organization. This position serves as the company’s senior advisor, implementer and administrator for regulatory strategies and regulatory compliance. Also serves as the Management Representative, Person Responsible for Regulatory Compliance (PPRC per IVDR) and HIPAA Privacy Officer. Provides leadership and development to assigned teams and staff. Serves as a member of Inova’s Executive Committee.
- Establishes, implements, and manages the overall regulatory affairs, quality assurance, quality control, and complaint handling functions to ensure the quality, safety, and reliability of all company products. This includes monitoring the complete manufacturing and QA/QC process to ensure conformance and compliance, as well as management of the Quality System, ensuring compliance with applicable local and i international regulatory requirements and/or programs including but not limited to the regulatory requirements of the U.S., Canada and other MDSAP countries, ISO 13485, IVDD, IVDR, FDA and c-GMP guidelines and HIPAA regulations.
- As a member of the senior management team, provides sound advice and guidance regarding the impact of regulatory and quality issues on overall corporate strategy and operations.
- Continuously identifies opportunities to improve the Quality System, product quality, simplify processes and/or reduce of the costs of quality.
- Manages the quality and regulatory staff and departmental resource needs.
- Provides leadership and management to ensure that the mission and core values of the company are put into place.
- Creates and leads a high-performing, innovative, management team that attracts, recruits, develops and retains exceptional staff.
- Reflect the values of Werfen and Inova as a role model to employees, customers, and business partners.
- Werfen People Manager competencies: Building talent, Driving for results, Customer focus, Driving for innovation, Emotional intelligence.
- Strategic thinking
- Leadership, coaching and mentoring
- Communication and influence
- Business acumen
- Financial management
- Technical Capacity
- Analysis and problem solving
Education, Experience, Skills and Knowledge
- Bachelor’s degree in life sciences or related field required; advanced degree or certification in Quality or Regulatory preferred.
- 10 plus years of experience in the medical device industry, including management experience required.
- Quality, regulatory and in vitro diagnostics/medical devices industry experience required, with extensive knowledge of strategic planning, US and worldwide regulations, quality and regulatory processes and experience interfacing with regulatory bodies, such as FDA, Notified Bodies and Competent Authorities required.
- Excellent knowledge of Quality Systems Regulations, IVDR and ISO regulations as they apply to device manufacturing required.
- Extensive experience interfacing with FDA and/or ISO, MDSAP auditors required.
- Excellent working knowledge of statistics, teamwork environments, workplace safety and complaint handling systems required.
- Outstanding verbal and written skills, utilizing critical thinking and organizational talents are required.
- Track record of success at building and leading high performing, complex teams.
This position is located in San Diego, CA and will require some travel.
Inova Diagnostics, Inc. provides an attractive compensation and benefits package.
Including: Company paid for employee: Medical, Dental, Vision, Life Insurance, 401K with a company match, Paid time off
- Remote interview process
- Personal protective equipment provided or required
- Social distancing guidelines in place
- Virtual meetings
- Sanitizing, disinfecting, or cleaning procedures in place
Notice to Agency and Search Firm Representatives: Inova Diagnostics, Inc. is not accepting unsolicited resumes from agencies and/or search firms for this job posting. Resumes submitted to any Inova employee by a third-party agency and/or search firm without a valid written & signed search agreement, will become the sole property of Inova. No fee will be paid if a candidate is hired for this position as a result of an unsolicited agency or search firm referral.
Inova Diagnostics, Inc. Appreciates and Values Diversity.
We do not discriminate based upon race, religion, color, national origin, gender (including pregnancy, childbirth, or related medical conditions), sexual orientation, gender identity, gender expression, age, status as a protected veteran, status as an individual with a disability, or other applicable legally protected characteristics.
Learn more here
Job posted: 2021-02-23