Job Description

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.

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