Senior Regulatory Affairs Program Lead (Robotics & Digital Solutions) - MedTech Surgery
About The Position
This role supports the Instrumentation & Accessories team within the Robotics & Digital Solutions group. The Senior Regulatory Affairs Program Lead will help achieve US and international regulatory (NPD) approval goals. The selected candidate will lead regulatory strategy development and execution for the robotic instruments and accessories portfolio. They will work closely with engineering and clinical teams, supporting product development stages, generating submission-ready documentation, and authoring regulatory submissions. Additionally, this individual will support health authority communications. The role requires instilling and driving a vibrant regulatory culture, applying strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals. It involves preparing and submitting regulatory information for global market access, including FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents. The position serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams, reviewing and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation. The role also involves proactively identifying issues, communicating timelines, addressing complex issues impacting registration status, conducting regulatory evaluations of changes to devices, and guiding conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. Assisting in the development of Regulatory Affairs processes is also a responsibility.
Requirements
- Minimum of a Bachelor's Degree required.
- Minimum of 6+ years of related Regulatory Affairs experience within Medical Device is required (4+ years with Advanced Degree).
- Experience with medical device regulatory new product submissions required.
- A demonstrated track record of developing and driving implementation of regulatory strategies.
- Working knowledge of how global regulations impact product registration.
- Good communication skills for effective collaboration with cross-functional partners.
- Corresponding and collaborating with colleagues globally for strategic contribution and achievement of regulatory milestones.
- Evaluating new regulatory requirements as well as regulatory changes and correctly assessing business impact.
- Excellent verbal and written communication skills; strong attention to detail.
- Advanced analytical and problem-solving skills.
- High organization skills with the ability to lead multiple projects/tasks simultaneously and effectively prioritize projects and tasks.
- Strong learning skills for complex technology and presentation skills to allow presentation of complex regulatory strategies in a clear, concise, and comprehensive fashion.
Nice To Haves
- Advanced Degree highly desired; desired areas of study include Science, Engineering, or related field.
- Previous experience with health authority meetings/interactions
- Experience with medical device software guidance, IEC 60601, sterilization, biocompatibility, and reprocessing requirements and their documentation in submissions.
Responsibilities
- Instills and drives a vibrant regulatory culture, working among cross functional groups as a teammate and collaborator.
- Applies strategic regulatory thinking along with technical expertise to develop and implement regulatory strategies for new product clearances and approvals.
- Prepares and submits regulatory information required to obtain global market access, including preparation, writing and filing of FDA submissions (e.g., Q-submissions, IDEs, De Novo, 510(k)s) and global health authorities’ submissions technical documents.
- Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. This includes conducting reviews and providing expert regulatory feedback for specifications, device testing, risk management, and other relevant documentation in accordance with regulatory requirements and with positioning for regulatory submission.
- Proactively identify issues, effectively communicate timelines for project completion, and address complex issues that may impact registration status.
- Conduct regulatory evaluation of changes to devices in accordance with requirements of commercial/operating geography and generate the required regulatory submission (including Letters To File).
- Guides conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials.
- Assists in the development of Regulatory Affairs processes.
Benefits
- Relocation assistance may be available on a case-by-case basis.
- Vacation –120 hours per calendar year
- Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 hours per calendar year
- Holiday pay, including Floating Holidays –13 days per calendar year
- Work, Personal and Family Time - up to 40 hours per calendar year
- Parental Leave – 480 hours within one year of the birth/adoption/foster care of a child
- Bereavement Leave – 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
- Caregiver Leave – 80 hours in a 52-week rolling period
- Volunteer Leave – 32 hours per calendar year
- Military Spouse Time-Off – 80 hours per calendar year
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What This Job Offers
Job Type
Full-time
Career Level
Senior
