Comar · 3 hours ago
Sr. Regulatory Specialist
Woodville, WI
Full-time
Onsite
Senior Level
5+ years expComar is a company focused on teamwork, innovation, and professional growth. They are seeking a Sr. Specialist in Regulatory Affairs to support regulatory activities, maintain regulatory databases, and ensure compliance with regulations for medical devices and packaging solutions.
Health CarePackaging Services
Responsibilities
Monitors the applicable regulations, and emerging trends regarding COMAR’s business scope of medical device and packaging solutions (i.e., container closures and food packaging) and report such changes promptly
Responds to customers’ regulatory requests expeditiously
Supports post market surveillance activities and appropriate actions in compliance with the regulations
Primary contact for customers for their Regulatory related inquiries. Supports customers’ regulatory submission needs
Owns Regulatory Affairs processes, procedures, and systems regarding UDI and drives metrics-based process improvements
Establishes a system to collect, track, analyze, and report on environmental compliance or material content regulations
Manages various regulatory consultants and services providers to maintain annual licenses, registrations, listings in applicable countries/region
Provides leadership, coaching and guidance to other staff to drive engagement, collaboration, sharing of best practices within their team and with other functions
Carries out administrative responsibilities in accordance with the organization’s policies and applicable laws
Qualification
Required
Bachelor's degree in a scientific or related discipline; or equivalent combination of education and experience
Minimum of 2 years of experience in an FDA regulated food or drug industry required
Minimum of 3 years hands-on experience in regulatory submissions including developing/ implementing regulatory strategies for medical device, in vitro diagnostic device and/or pharmaceutical industry
Experience with medical device regulations in the US and international markets such as Canada, Europe, and UK etc
Thorough understanding of UDI, submission, and registration requirements to applicable FDA & EU/UK medical device regulations
Thorough understanding of global food safety regulations, standards, and best practices
Preferred
Knowledge of plastics manufacturing processes and technology platforms, commonly used especially in medical devices or in pharma packaging
Knowledge of 510(k), Device Establishment Registration and Listings, Technical File preparation processes
Knowledge of US and EU UDI requirements
Benefits
Employee training platforms
Volunteering opportunities
Sustainability initiatives
Company
Comar
Comar is a specialty packaging and dispensing provider.
501-1000 employees
Funding
Current Stage
Late StageTotal Funding
unknown2025-11-04Acquired
2021-12-01Private Equity
2018-06-19Private Equity
Leadership Team
Brian Larkin
President and Chief Executive Officer
Recent News
Mergers & Acquisitions
2025-11-08
2025-11-08
Business Wire
2025-11-04
Company data provided by crunchbase