Provide strategic regulatory guidance to business leadership
Develops and implements strategies to achieve timely global commercialization of products in compliance with applicable regulations and standards
Ensure comprehensive and compliant support of released products and support internal and external audits
Develops and maintains ongoing relationships with global regulatory partners and regulatory authorities
Establish and maintain internal controls to ensure compliance as required by regulatory authorities
Lead a strong, diverse regulatory affairs team with the competencies required to support a global portfolio in an evolving regulatory landscape
Review advertising and promotional materials

Bachelor’s degree in scientific/technical field required
Minimum 15 years prior experience in regulatory affairs, clinical, quality and/or product development (or 13 years with Masters or other advanced degree)
Minimum of 10 years of managerial experience
10+ years of Regulatory Affairs experience preferred, ideally in the cardiovascular space
Extensive regulatory knowledge and experience across a wide variety of product classifications; including higher classification devices (i.e. Class III PMA, Class III EU)
Deep knowledge of pre
and post-market compliance requirements
Ability to negotiate with regulatory agencies

Health, Dental and vision insurance
Health Savings Account
Healthcare Flexible Spending Account
Life insurance
Long-term disability leave
Dependent daycare spending account
Tuition assistance/reimbursement
Simple Steps (global well-being program)
Incentive plans
401(k) plan plus employer contribution and match
Short-term disability
Paid time off
Paid holidays
Employee Stock Purchase Plan
Employee Assistance Program
Non-qualified Retirement Plan Supplement (subject to IRS earning minimums)
Capital Accumulation Plan (available to Vice Presidents and above, or subject to IRS earning minimums)

Senior Regulatory Affairs Director

Key skills