Job Title: Regulatory Affairs Manager
Location: Philadelphia, PA (Remote within the same time zone)
Experience: 10+ Years
Job Overview:
The Regulatory Affairs Manager will support regulatory activities for the commercialization of new digital and AI-enabled products, including Software as a Medical Device (SaMD). This role involves providing regulatory guidance to cross-functional teams, ensuring compliance with relevant regulations, and interacting with regulatory authorities as needed.
Key Responsibilities:
Serve as the Regulatory Affairs representative on cross-functional project teams, providing strategic guidance on product lifecycle planning and regulatory requirements for medical and non-medical devices.
Assess regulatory acceptability of documentation and provide clear guidance on submissions.
Assist in the development and review of SOPs supporting next-generation products.
Compare regulatory outcomes with initial product concepts and recommend future actions.
Research regulatory history and therapeutic context to assess implications for approval.
Create and maintain technical documentation, including clinical evaluation reports, risk management reports, and 510(k) notifications.
Support preparation and review of regulatory submissions to authorities.
Evaluate proposed design, labeling, and distribution changes for regulatory impact and implement required actions.
Provide strategies on complex regulatory issues and ensure post-market compliance.
Review product labeling for regulatory compliance.
Mentor and guide less experienced team members when needed.
Work with clinical teams to ensure compliance in pre- and post-market clinical studies.
Ensure timely reporting of adverse events to regulatory authorities.
Qualifications:
Bachelor's degree in a relevant field or equivalent experience.
10+ years in a regulated industry; experience with FDA and SaMD preferred.
Strong knowledge of FDA Quality System Regulations (21 CFR 11, 21 CFR 820).
Experience drafting and submitting regulatory filings, including Q-Submission requests and Traditional/Special 510(k) submissions; SaMD filings preferred.
Experience with US FDA Class I and II medical devices; Class III and OUS device experience is a plus.
Experience interacting with OUS regulatory authorities and participating in regulatory inspections.
Knowledge of pre- and post-market clinical study regulations (21 CFR 812, 50, 56).
Familiarity with Medical Device Regulations (MDR 2017/745, MDCG 2019-11, MDCG 2020-1), ISO 13485, MDSAP, ISO 14971, ISO 62366, IEC 82304-1, and IEC 62304 preferred.
Excellent written and oral communication skills.