Senior Regulatory Affairs Program Lead – MedTech Surgery

This is a fully remote position, open to applicants in California.

📋 Description

• Cultivates and promotes a dynamic regulatory culture, collaborating effectively with cross-functional teams as a partner and contributor.

• Employs strategic regulatory insights alongside technical knowledge to formulate and execute regulatory plans for new product clearances and approvals.

• Gathers and submits regulatory documentation necessary for securing global market access.

• Drafts and files submissions to the FDA (e.g., Q-submissions, IDEs, 510(k)s).

• Acts as a Regulatory Affairs expert within new product development and engineering design control teams.

• Proactively identifies potential issues, clearly communicates timelines for project completion, and addresses complex matters that may affect registration status.

• Guides compliance with relevant regulations and guidance documents during product development, claim support, content labeling, and promotional material creation.

• Aids in the development and refinement of Regulatory Affairs processes.

⛳️ Requirements

• A Bachelor's Degree or higher is required.

• At least 6+ years of relevant Regulatory Affairs experience in the Medical Device sector is essential.

• Proven experience with regulatory submissions for Class II medical devices is mandatory.

• Prior experience in health authority meetings/interactions is required.

• A proven history of formulating and implementing regulatory strategies is essential.

• Familiarity with Cybersecurity regulations and requirements for software as a medical device, including devices utilizing AI/ML.

• Understanding of requirements for medical devices with electronic components and related testing (IEC 60601).

• Exceptional communication skills to facilitate effective collaboration with cross-functional teams.

• Strong attention to detail is necessary.

• Ability to evaluate new regulatory requirements and changes, along with accurately assessing their business impact.

🏝️ Benefits

• Pension and savings plan (401(k)).

• Vacation – 120 hours per calendar year.

• Sick time - 40 hours per calendar year.

• Holiday pay, including Floating Holidays – 13 days per calendar year.

• 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.