Translate complex regulatory requirements into clear, practical implementation strategies, ensuring that regulations are reflected accurately and efficiently within business processes, and supporting digital systems.
Lead regulatory strategy and implementation for AI-driven digital and data initiatives, ensuring development of validated, compliant processes and tools to collect, manage, and analyze data that strengthen our competitive position and meet evolving external data
and systems-related regulatory requirements.
Establish and optimize procedures governing the creation, maintenance, and utilization of regulatory data to ensure integrity, traceability, and compliance.
Build organizational capabilities in regulatory data standards, processes, and systems.
Serve as the primary contact for enterprise-wide initiatives, influence, and drive alignment with interested parties.
Translate Regulatory Affairs’ needs into actionable business requirements to guide the design, development, and deployment of IT solutions, digital tools, and data platforms.
Support policy efforts by providing input on emerging regulations, industry guidance, and trade association activities.
Lead organizational readiness for data submissions to external databases (e.g., EUDAMED) including defining data requirements, conducting gap analysis, and ensuring process and system preparedness.

Minimum of a Bachelor’s Degree required , Advanced Degree strongly preferred .
At least 6+ years regulatory affairs experience within a highly regulated industry required , Medical Device strongly preferred .
Compliance & governance for Unique Device Identification (UDI) is required .
System implementation experience is required .
Experience implementing AI into processes & workflows is highly desired .
Knowledge of regulatory requirements in the EU and US, with proven track record of translating regulatory requirements into clear data, system, and business processes.
Excellent written and verbal communication skills.
RAC Certification strongly preferred .

Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
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

Senior Regulatory Affairs Program Lead – Data Strategy, MedTech Surgery

Key skills