Sr. Regulatory Specialist

Comar • Woodville, WI

5d

About The Position

Sr. Specialist, Regulatory Affairs Our Corporate Quality team has an immediate opening for a Sr. Specialist, Regulatory Affairs who is ready to take their career to the next level. As a Sr. Specialist, Regulatory Affairs at Comar you will be a critical member of the team responsible for regulatory activities to support the day-to-day business, including maintaining regulatory databases to improve current processes within the department. This role will also provide hands on support for the coordination, compilation, and submission of various Unique Device Identification for Comar’s products in the applicable global UDI databases, as well as collaborate and provide strategies for regulatory compliance, drive alignment with internal and external stakeholders, and develop and implement compliance plans. Are you a Regulatory Affairs professional looking to make a difference with a company that values teamwork, innovation, and professional growth? One of our Core Values is “Work Together, Win Together.” Come work and win with us today! What you will do: Regulatory Strategy: · 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. Regulatory Support: · 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. Process Ownership and Process Improvements: · 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. Resources / People Management: · 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.

Requirements

• 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
• Inquisitive, self-motivated, excellent initiative qualities with strong mentoring / coaching skills.
• Strong computer skills (Microsoft office suite, database administration, ERP, CMMS).
• Ability to interact with individuals at all levels of the organization, strong written and oral communication skills, and excellent organizational skills with attention to detail.
• Ability to prioritize multiple tasks and demands and to create sense of urgency for the fast-paced manufacturing environment.
• Strong customer focus

Nice To Haves

• 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.

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.

What This Job Offers

• Job Type: Full-time
• Career Level: Mid Level