Manager, Regulatory Affairs – Digital Health

Role Overview

• The Regulatory Affairs Manager, Digital Health, in partnership with the Director, RA Digital Health and the RA team, will be responsible for developing and executing 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 our global regulatory teams as we expand our product approvals across geographies.
• Partner with global teams to inform regulatory requirements as a key member of cross-functional teams.
• Prepare and review FDA submissions, and interact with and respond to FDA pre-submission during the review period.
• Support global regulatory teams as an interface with the 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, and 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 for situations.
• Provide regulatory support for currently marketed products as necessary to ensure ongoing compliance.
• Provide support for changes to existing products, including providing regulatory assessment of changes and subsequent regulatory filings.
• Develop solutions to a variety of technical problems.
• Actively participate in problem solving discussions and recommend solutions.
• Keep abreast of global Digital Health guidance documents and regulations and monitor impact of changing regulations on submission strategies.
• 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 ; Computer Science/Engineering discipline highly desired .
• At least 6+ years Regulatory Affairs experience (5+ with Advanced Degree) in the medical device space is required ; experience with complex networked device ecosystems like Cardiac Electrophysiology, Diabetes, Neuromodulation, Robotic Surgery etc. strongly preferred .
• 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.
• Ability to effectively manage multiple projects and priorities.
• 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.
• Ability to comprehend principles of engineering, physiology and medical device use.
• 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%

Tech Stack

• Cyber Security

Benefits

• Subject to the terms of their respective plans, employees are eligible to participate in the Company’s consolidated retirement plan (pension) and savings plan (401(k)).
• Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
• Vacation –120 hours per calendar year
• Sick time
• 40 hours per calendar year; for employees who reside in the State of Colorado –48 hours per calendar year; for employees who reside in the State of Washington –56 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 period10 days
• Volunteer Leave – 32 hours per calendar year
• Military Spouse Time-Off – 80 hours per calendar year