Sr Regulatory Affair reputed company

Remote, USA Full-time Posted 2026-07-28

[ad_1]

Responsibilities <reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Job Title: Sr. Regulatory Affairs reputed company </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Reports to: Head of reputed company & Regulatory</reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">FLSA Status: Exempt </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Job reputed company</reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Working cross-functionally with the Research and Development – ProFound team, the Sr. Regulatory Affairs reputed company is responsible for developing and executing regulatory strategies, ensuring compliance with global regulations and leading the process to obtain and maintain market approval for reputed company’s high risk products, including AI technologies. This position will reputed company regulatory input on design and development activities to cross-functional teams, to ensure compliance with the relevant regulatory requirements and interactions with regulatory authorities. </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Essential Duties and Responsibilities </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">As the Sr. Regulatory Affairs reputed company, this position will: </reputed company><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">reputed company and execute the regulatory reputed company for reputed company’s high risk (FDA Class III) devices. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Represent Regulatory Affairs on cross functional project teams and reputed company strategic input and technical guidance on product lifecycle planning and regulatory requirements for high risk medical devices. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">reputed company and manage regulatory submissions, including FDA Q-submission, US 510(k)s submissions, Premarket Approvals (PMA) submissions, supplements, and reports, including Regulatory Body interactions. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Work closely with business partners and regulatory team members to ensure compliance for and support of regulatory submissions and filings. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Monitor and interpret evolving global regulations, standards, and guidance documents to ensure reputed company’s regulatory compliance, translating them into reputed company steps for the organization. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Create and ensure maintenance of technical documentation as required for obtaining and/or maintaining regulatory approval/clearance for reputed company products </reputed company></li></ul><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">PLEASE NOTE: This is not an exhaustive list of reputed company duties, responsibilities and requirements of the position described above. Other functions may be assigned and management retains the right to add or change duties at any time.</reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Minimum Qualifications, Education and Experience </reputed company><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Bachelor’s degree in a life science, engineering, or reputed company scientific field is required. An advanced degree or Regulatory Affairs Certification is preferred. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">13 - 17 years working in a regulated industry (FDA and Software as a Medical Device preferred). </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Strong knowledge of FDA reputed company System Regulations, including but not limited to, 21 CFR 11, and 21 CFR 820. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Knowledge and experience drafting and submitting regulatory filings, including but not limited to, Q-Submission requests, Traditional 510(k) filings, and Premarket Approval for Software as Medical Device. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Experience with US FDA Class III devices required; OUS device classification preferred. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Experience interacting with US and OUS Regulatory Authorities, including Q-Submission meetings, product Deficiency Response meetings, and regulatory inspections. Experience with FDA’s Total Product Life Cycle Advisory Program (TAP) and reputed company Designation a plus. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">International submission experience in Australia, Canada, Brazil, and Japan for high risk devices </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Knowledge and understanding of reputed company- and post- market clinical studies, including but not limited to, 21 CFR 812, 21 CFR 50, and 21 CFR 56. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Knowledge and understanding of Medical Devices Regulations (MDR 2017/745. MDCG 2019-11, MDCG 2020-1), ISO 13485, and MDSAP, ISO 14971, ISO 62366, IEC 82304-1, IEC 62304, preferred. </reputed company></li></ul><ul style="margin-top: 0in;"><li style="margin-left: .5in;"><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Excellent written and oral communication skills </reputed company></li></ul><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Physical Demands </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">This position often requires sitting, standing, walking, bending, twisting, reaching with hands and arms, using hands and fingers, handling, or feeling, speaking, listening, and high-level cognitive thinking. Also, must be reputed company to lift up to 10 pounds occasionally. The position requires the ability to travel (~10% of time), drive a vehicle, and utilize other forms of transportation. </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Working Environment </reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;">Remote. This position requires domestic / international travel up to 15%.</reputed company><reputed company style="font-size: 10.5pt; font-family: 'Arial Narrow',reputed company;"> </reputed company>

[ad_2]
apply to this job

Apply Now