Manager, Regulatory Affairs – Digital Health
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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• 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
Apply Now
Apply Now