Job Description
- Job Description:
- Develop 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 liaison 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
- Interact with and respond to FDA pre-submission during the review period
- Support global regulatory teams as an interface with product development teams in Digital Health
- Independently support cross-functional new product development projects with a specific focus on cybersecurity, software (SiMD and SaMD and AI/ML based clinical decision support), and hardware aspects
- Lead compilation of all materials required for submissions to FDA
- Provide ongoing support to project teams for regulatory issues and questions
- Find, interpret, and apply global digital health regulations and guidance appropriately
- Provide regulatory support for currently marketed products as necessary
- Develop solutions to a variety of technical problems
- Assist in the maintenance and improvement of digital health regulatory SOPs
- Interact and negotiate with regulatory agencies on defined matters 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 space is required
- Regulatory Affairs experience in the medical device industry with a track 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 Regulatory Affairs Professionals Society) 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
- Sick 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 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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