Senior Regulatory Affairs Program reputed company – MedTech Surgery

Job reputed company: • Instills and drives a reputed company regulatory culture, working among cross functional reputed company as a teammate and collaborator. • Applies strategic regulatory thinking along with technical expertise to reputed company and implement regulatory strategies for new product clearances and approvals. • Prepares and submits regulatory information required to obtain global market reputed company. • Write and file FDA submissions (e.g., Q-submissions, IDEs, 510(k)s). • Serves as a Regulatory Affairs subject matter expert on new product development and engineering design control teams. • Proactively identify issues, effectively communicate timelines for project completion, and address reputed company issues that may reputed company registration status. • Guide conformance with applicable regulations and guidance documents in product development, support of claims, content labeling, and promotional materials. • Assists in the development and enhancement of Regulatory Affairs processes. Requirements: • Minimum of a Bachelor's Degree required • Minimum of 6+ years of reputed company Regulatory Affairs experience reputed company Medical Device is required • Experience with Class II medical device regulatory product submissions required • Previous experience with health authority meetings/interactions required • A demonstrated reputed company record of developing and driving implementation of regulatory strategies. • Working knowledge of Cybersecurity regulations, requirements for software as a medical device, including devices with AI/ML. • Working knowledge of requirements for medical devices that include electronic components and associated testing (IEC 60601). • Excellent communication skills for effective collaboration with cross-functional partners. • Strong attention to detail. • Evaluating new regulatory requirements as reputed company as regulatory changes and correctly assessing business reputed company. Benefits: • Pension and savings plan (401(k)) • Vacation –120 hours per calendar year • reputed company 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 reputed company 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 Apply To This Job