Sr. Manager, Regulatory

Position Summary:

Regulatory manages global product registrations and post market surveillance for all medical device products and good manufacturing practices. Additional activities include drafting standard operating procedures, assessment of product modifications, and supporting new product development teams.

Responsibilities:   

• Responsible for leading department and cross functional support of new product development teams. 
• Collaborates as a liaison to internal and external customers: 
  1. Ensure timely interactions with regulatory agencies for submissions and audits with proper document production.
  2. Participates and assists distributors, local representatives, and consultants with immediate action of operational issues and complaints.
• Responsible for strategy and preparation of regulatory submissions including 510(k) premarket notifications for US FDA, technical files/design dossiers for European Union, and interfaces as needed with Notified Bodies for significant changes.
• Ensure compliance with medical device regulations (e.g., QSR and MDR), consensus standards, and the Quality Management System.
• Responsible for creation of Summary Technical Documentation (STED) and Technical Files for assigned products including maintenance of risk management files, post-market surveillance, and clinical evaluation with cross-functional leads.
• Responsible for process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
• Review product labeling and promotional materials to ensure consistency with regulatory approvals.
• Other duties as assigned.

Preferred Competencies and Experience:

• CFR Title 21, ISO 13485, EU MDR, and other Quality System standards
• US FDA premarket and special controls requirements for orthopedic implants and sterile packaged surgical instruments
• IEC Standards for Software, Medical Electrical Safety, and Cybersecurity
• American Association of Tissue Banks (AATB) and 21 CFR 1271

Education/Certification Required:

• At least 7 years of experience in functional area
• Bachelor’s Degree in Life Sciences required
• Lead auditor and Regulatory Affairs Certification (RAC) are desired