Minimum Knowledge & Experience:
Education:
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Bachelor’s degree life sciences or related field required, advanced degree in Quality or Regulatory strongly preferred.
Experience:
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At least ten (10) years Quality & Regulatory corporate leadership experience, within the medical device industry required.
- Demonstrated experience leading organizational change required, within a regulated industry.
Management has the discretion of substituting relevant work experience for a degree and/or making exceptions to the years of experience requirement.
Skills & Capabilities:
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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, Product Change Requests 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.
The annual base salary range for this role is currently $240,000–$280,000 annually. Individual employee compensation will ultimately depend on factors including education, relevant experience, skillset, knowledge, and particular business needs.
This role is eligible for medical, dental, and vision insurance, 401k plan retirement benefits with an employer match, as well as paid vacation and sick leave. Our sales roles are eligible for participation in a commission plan and our management, and select professional roles, are eligible for a performance-based bonus.
Travel requirements:
25% 25% or more, includes international travel
