Manager, Regulatory Affairs – Digital Health

ComplianceComplianceFull TimeRemoteTeam 10,001+Since 1886H1B SponsorCompany Site LinkedIn

Location

Massachusetts

Posted

17 days ago

Salary

$117K - $201.3K / year

Bachelor Degree6 yrs expEnglishCyber Security

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

Job 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