Compliance Advisor II supporting enterprise - wide compliance operations at AltaMed. Involves audits, training, policy drafting, and compliance queries with healthcare focus.
About the role
- Leading Regulatory Affairs for Medtronic's Affera platform focusing on compliance and product innovation. Managing regulatory strategies and team responsibilities for timely product commercialization.
Responsibilities
- 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
Requirements
- 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
Benefits
- 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)
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