Location: Philadelphia, PA (Remote must be within Eastern Time Zone)
Experience: 10+ years
Industry: Medical Device
We're looking for a Regulatory Affairs Manager with a strong background in medical devices and deep experience in 510(k) submissions for Software as a Medical Device (SaMD) products. This role is ideal for someone who's well-versed in navigating the FDA regulatory landscape, can lead submissions from start to finish, and collaborate closely with cross-functional teams to ensure full regulatory compliance throughout the product lifecycle.
Key ResponsibilitiesLead and prepare regulatory submissions including 510(k) , Technical Files , and Design Dossiers for SaMD and medical device products.
Develop and execute regulatory strategies to support product development, registration, and post-market activities.
Interpret and apply global regulatory requirements (FDA, EU MDR, ISO 13485, IEC 62304) for SaMD.
Review design and development documentation to ensure compliance with applicable regulations and standards.
Communicate effectively with regulatory authorities and manage submission timelines and responses to inquiries.
Partner with R&D, Quality, and Clinical teams to ensure product documentation meets regulatory standards.
Monitor changes in relevant regulations and standards, assessing impact on existing and future products.
Support internal audits, inspections, and risk management activities related to regulatory compliance.
Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, or a related discipline. (Master's preferred)
10+ years of experience in regulatory affairs within the medical device industry.
Proven track record of authoring and submitting successful 510(k) submissions for SaMD products.
Strong understanding of FDA , ISO 13485 , IEC 62304 , ISO 14971 , and EU MDR regulatory frameworks.
Experience working cross-functionally with engineering, clinical, and quality teams.
Excellent documentation, communication, and project management skills.
Regulatory Affairs Certification (RAC) or equivalent credential.
Experience with software lifecycle documentation and cybersecurity requirements for SaMD.
Knowledge of AI/ML-based SaMD regulatory considerations.
Familiarity with international submissions (Health Canada, EU, etc.).
...impairments. Welook for candidates who enjoyworking in a fast-paced, goal-oriented... ...including web pages, guides,eBooks, email, social, paid media, video support, sales enablement, and... ...Demands Incumbent works from home and is expected to maintain a safe, productive...
...direct care, home health and those with a desire to help others. We are seekingPart-timeemployees to work the overnight Sleep Shift from 11:00pm-8:30am. No experience necessary, we provide paid ORIENTATION & TRAINING. Great opportunity for students who need extra...
...Roofing, our purpose isBuilding a SweeterExperienceand our Production Runners play a key role in making that happen on job sites every... ...in accordance withcompany policies and safety standards~ Assistwith basic site oversight and support production team needs as...
...organizations for the past six consecutive years. The company is a division of Compass Group and has more than 1,200 registered dietitians, 300 executive chefs, and 17,000 professional food service team members. Job Summary We are seeking a Clinical Dietitian (...
...RN, Registered Nurse Corrections, Correctional, Psych, Forensics, Detox or related nursing experience. Beaumont, VA + Additional openings statewide! Overview: ~$50/hour. ~$75/hour overtime. ~ Plus weekend differential. ~12-hour shifts. ~36 hours weekly...