Sr Prin Regulatory Affair Spec
About The Position
The Senior Principal Regulatory Affairs Specialist will provide strategic regulatory leadership for multiple complex product development programs, with a particular focus on AI‑enabled technologies. This role is responsible for developing and executing global regulatory strategies, leading the planning, preparation, and submission of high‑quality regulatory filings, and ensuring alignment with evolving regulatory expectations for innovative digital and AI‑driven solutions. The individual will manage multiple workstreams, collaborate closely with cross‑functional partners, and proactively identify and mitigate regulatory risks to support timely approvals and successful market access. This position is intended for an experienced regulatory professional who can operate with a high degree of independence, while managing concurrent projects, influence strategy across programs, and help build long‑term regulatory capability within the organization.
Requirements
- Bachelors degree required
- Minimum of 10 years of relevant experience, or advanced degree with a minimum of 8 years of relevant experience.
- Experience in software, cybersecurity, and AI/ML related regulatory submissions.
Nice To Haves
- Experience with FDA pre-determined change control plan (PCCP) submissions.
- Clinical trial submissions.
- Regulatory review of advertising and promotion materials.
Responsibilities
- Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
- Leads or compiles all materials required in submissions, license renewal and annual registrations.
- Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
- Monitors and improves tracking / control systems.
- Keeps abreast of regulatory procedures and changes.
- May direct interaction with regulatory agencies on defined matters.
- Recommends strategies for earliest possible approvals of clinical trials applications.
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)
Stand Out From the Crowd
Upload your resume and get instant feedback on how well it matches this job.
What This Job Offers
Job Type
Full-time
Career Level
Principal
