Director, Regulatory Affairs Strategy overseeing regulatory strategy and product approvals for Alcon. Leading regulatory teams and ensuring compliance across Alcon’s franchise portfolios.
About the role
- Senior Principal Regulatory Affairs Specialist at Medtronic leading regulatory strategies for Class II robotic devices. Responsible for compliance with US and EU regulations and product lifecycle support.
Responsibilities
- Develop and support global regulatory strategies for Class II devices and accessories for robotic surgical application.
- Be an active member of the product development core teams and responsible for identifying submission deliverables, timelines, and strategic direction.
- Reviews and approves technical documentation.
- Provide feedback and work with engineers and technical experts to resolve potential regulatory issues and questions from regulatory agencies and provide ongoing support to product development teams to assure timely resolution to regulatory issues and questions.
- Prepare FDA IDE submissions, DeNovo/510(k) submissions, or EU submissions for new products and product changes as required.
- Directly communicates with regulatory authorities to resolve questions/issues that arise prior to and during product submissions or other pertinent issues.
- Participate in the product change assessments and define the regulatory impact of product changes in global markets.
- Provide support to market released products as necessary. This includes reviewing labeling, product changes, and documentation for changes requiring regulatory approval.
- Keeps abreast of new and changing global regulatory requirements and keep the business informed of implications of changes.
- Collaborate with International regulatory teams to understand worldwide regulatory requirements to enable the development of strategies and requirements for global commercialization.
- Interact directly with major market regulatory agencies in support of product registration, approval, and commercialization.
- Leads or performs coordination and preparation of document packages for global regulatory submissions, license renewals, internal & external audits and inspections.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Plays an active role in continuous improvement of regulatory processes for the Robotics Business Unit.
Requirements
- Bachelor’s degree required
- Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
- Degree in Engineering
- Experience with US and EU submissions (e.g. 510(k), PMA, Pre-Sub, PCCP, IDE, MDR, etc.) with complex medical device systems including hardware, software and artificial intelligence
- Demonstrated ability for strategic thinking, project planning
- Strong influence skills.
- Demonstrated ability to work cooperatively at all levels in an organization to build and maintain relationships required to accomplish program goals
- Ability to balance priorities, work independently or collaboratively to determine and develop solutions
- Excellent verbal/ written communication and presentation skills.
- Demonstrated ability to succinctly and accurately communicate to various cross functional partners.
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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