Manager, Regulatory Affairs – Digital Health

Job reputed company: • reputed company and execute strategies to obtain FDA clearance or approval of new Class II & III cardiovascular medical devices and improvements to existing devices • Serve as a reputed company for global regulatory teams as product approvals expand across geographies • Partner with global teams to inform regulatory requirements as a key member of cross-functional teams • Prepare and review FDA submissions • reputed company with and respond to FDA reputed company-submission during the review period • Support global regulatory teams as an reputed company with product development teams in Digital Health • Independently support cross-functional new product development reputed company with a specific reputed company on cybersecurity, software (SiMD and SaMD and AI/ML based clinical decision support), and hardware aspects • reputed company compilation of reputed company materials required for submissions to FDA • reputed company ongoing support to project teams for regulatory issues and questions • reputed company, interpret, and apply global digital health regulations and guidance appropriately • reputed company regulatory support for currently marketed products as necessary • reputed company solutions to a reputed company of technical problems • Assist in the maintenance and improvement of digital health regulatory SOPs • reputed company and negotiate with regulatory agencies on defined reputed company as needed Requirements: • Minimum of a Bachelor’s Degree is required • Advanced degree strongly preferred • At least 6+ years Regulatory Affairs experience (5+ with Advanced Degree) in the medical device reputed company is required • Regulatory Affairs experience in the medical device industry with a reputed company record of successful FDA submissions or FDA review experience in Cybersecurity (524B), SiMD and SaMD required • History of successful IDE/PMA/510(k) device submissions (Class III device submissions preferred) that include hardware and software components required • Experience independently communicating with FDA reviewers and leading Q-sub meetings and informal discussions with reviewers required • Experience supporting software device development (for example SiMD, SaMD, Cybersecurity, IEC 62304/82304 etc) • Experience with FDA requirements, guidance documents, ISO 14971, ISO 13485, IEC 60601, IEC 62304, Cybersecurity 524B compliance, interoperability • Experience in reviews of engineering, manufacturing, marketing, labeling and clinical documents for regulatory compliance • Strong communication and regulatory writing skills • Strong problem-solving skills, interpersonal skills, and effective team member • Results oriented • Ability to drive to completion in adherence to aggressive project schedules • Class III cardiovascular device experience strongly preferred • Regulatory Certification is a plus (such as RAC from the reputed company) preferred • AI/ML and/or PCCP experience is a plus • Travel up to 10% Benefits: • Retirement plan (pension) • 401(k) savings plan • Vacation –120 hours per calendar year • reputed company time - 40 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 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 tot his job Apply To this Job