Associate Regulatory Affairs Specialist - On-site
About The Position
The Cranial and Spinal Technologies (CST) Operating Unit develops and delivers technologies for treating spinal and cranial conditions. The organization partners with healthcare professionals worldwide to support procedural planning, navigation, biologics, implants, and enabling technologies designed to improve patient outcomes. The Regulatory Affairs function supports product compliance and regulatory strategy throughout the product lifecycle by coordinating submissions, registrations, renewals, and regulatory documentation. This team collaborates with cross-functional stakeholders to help ensure products, processes, and labeling activities meet applicable regulatory requirements while supporting business objectives within the CST portfolio. This position is based in Memphis, Tennessee, and is an on-site role. No travel is required. The Associate Regulatory Affairs Specialist supports regulatory activities for the Cranial and Spinal Technologies portfolio by coordinating documentation, preparing submission materials, maintaining regulatory records, and assisting with compliance initiatives. This role partners with cross-functional teams to help ensure timely and accurate regulatory submissions while supporting regulatory inspections, audits, and ongoing business operations.
Requirements
- Bachelor's degree
Nice To Haves
- Experience supporting regulatory submissions, registrations, renewals, or regulatory compliance activities.
- 1+ year of experience in Regulatory Affairs, Quality, Clinical, Medical Device, Life Sciences, Healthcare, or another regulated environment.
- Knowledge of United States and/or international regulatory requirements and regulatory documentation practices.
- Experience using Microsoft Office applications, including Word, Excel, Outlook, and PowerPoint.
- Experience using regulatory information management, document control, or quality management systems.
- For Baccalaureate degrees earned outside of the United States, a degree that satisfies the requirements of 8 C.F.R. § 214.2(h)(4)(iii)(A) is required.
Responsibilities
- Coordinate the preparation, assembly, and maintenance of regulatory submission packages and supporting documentation.
- Compile materials required for regulatory submissions, license renewals, annual registrations, and related filings.
- Support internal and external audits, inspections, and regulatory inquiries by gathering and organizing requested documentation.
- Review regulatory documentation and recommend updates to labeling, manufacturing processes, marketing materials, and clinical protocols to support compliance requirements.
- Maintain and improve systems used to track regulatory submissions, commitments, approvals, and records.
- Monitor regulatory requirements, guidance updates, and procedural changes to support ongoing compliance activities.
- Collaborate with cross-functional teams to ensure regulatory deliverables are completed accurately and according to established timelines.
- Support regulatory strategies and activities associated with obtaining and maintaining product approvals and registrations.
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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What This Job Offers
Job Type
Full-time
Career Level
Entry Level
