Regulatory Affairs Specialist - On-site
About The Position
The Regulatory Affairs Specialist is an individual contributor role within the Cranial & Spinal Technologies Operating Unit, responsible for planning and delivering regulatory projects that support timely market access and ongoing compliance. This position works cross‑functionally to prepare, publish, and manage high‑quality regulatory submissions and related documentation, leveraging specialized knowledge of regulatory requirements and electronic document systems. The role may mentor colleagues or provide direction to lower‑level professionals while ensuring work is delivered in alignment with Medtronic policies, procedures, and quality standards. At Medtronic, we bring bold ideas forward with speed and decisiveness to put patients first in everything we do. In-person exchanges are invaluable to our work. We’re working a minimum of 4 days a week onsite as part of our commitment to fostering a culture of professional growth and cross-functional collaboration as we work together to engineer the extraordinary.
Requirements
- Baccalaureate degree
- Minimum of 2 years of relevant experience in a regulated industry
Nice To Haves
- Experience with regulatory or other complex data systems, including data entry, reporting, and troubleshooting.
- Demonstrated ability to analyze data and metrics to inform decision‑making and process improvements.
- Strong cross‑functional collaboration skills and experience working with diverse stakeholder groups.
- Experience preparing or contributing to regulatory submissions (e.g., eCTD, marketing applications, annual reports, amendments, or adverse event reporting).
- Strong attention to detail, organizational skills, and ability to manage multiple projects and deadlines.
- Effective written and verbal communication skills, including clear report‑outs to leadership.
- 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
- Prepare, publish, perform quality control, and deliver paper and electronic components of regulatory submissions, including initial large marketing authorization applications and electronic common technical documents (eCTD).
- Produce submissions using electronic publishing tools in compliance with document management standards and applicable regulatory/quality requirements.
- Manage activities related to enterprise-wide regulatory management systems, including systems coordination, user support, and data maintenance.
- Develop and deliver training for colleagues on regulatory systems, tools, and related processes.
- Contribute to the development, implementation, and continuous improvement of regulatory systems and processes, including input to system design and enhancements.
- Prepare, submit, track, index, and archive paper and electronic submissions such as supplements, amendments, annual reports, general correspondence, adverse event reports, and promotional material filings.
- Collaborate cross‑functionally (e.g., with R&D, Quality, Clinical, Marketing) to collect required information, resolve issues, and provide clear regulatory status updates, including report‑outs to leadership.
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
Principal
