Regulatory Affairs Specialist

Patterson Companies, Inc.•Saint Paul, MN

About The Position

Patterson isn't just a place to work, it's a partner that cares about your success. One of the distinguishing marks of our company is the talented people who embrace the people-first, always advancing, and results-driven culture. Professional growth abounds in this motivating environment. We value the diverse talents and experiences our employees bring to Patterson and believe that they build a stronger and successful organization. The Regulatory Affairs Specialist is responsible for ensuring comprehensive compliance with regulatory requirements throughout the entire product lifecycle — from initial development and manufacturing to distribution and post-market surveillance. This role ensures that products meet established standards for safety, efficacy, and quality. Key responsibilities include obtaining and maintaining regulatory approvals, supporting cross-functional teams, and ensuring alignment with applicable laws, regulations, and industry standards. These include, but are not limited to, the U.S. Food and Drug Administration (FDA), Canadian Medical Device Regulations (CMDR), and European Union Medical Device Regulation (EU MDR).

Requirements

Bachelor's Degree in Business, Law, Regulatory Affairs or related field or equivalent education and/or experience
2 years experience in regulatory affairs within the medical device and drug related regulatory field experience with QMS and regulatory systems

Nice To Haves

Experience with Health Canada regulated environment
Knowledgeable in QMS (Quality Management System) regulations (not limited to) 21 CFR Part 820, ISO 13485, CMDR, GUI-0001 and others as applicable
Understanding of global medical device regulations (e.g., FDA QSR, EU MDR, Canada MDR, MDSAP and ISO standards)
Ability to work effectively within a team and as an individual contributor in a fast-paced changing environment -- multi-tasks, prioritizes and meet deadlines in timely manner
Strong verbal and written communications with ability to effectively communicate at specialist and line management levels in the organization; strong customer service-oriented skills
Strong organizational, analytical, and creative problem-solving skills and track record contributing to teamwork practices with a moderate impact on functional objectives
Highly self-motivated and directed; able to carry out responsibilities with latitude and limited supervision

Responsibilities

Authors global Regulatory Strategies by applying acquired skills and knowledge to processes and procedures and interpreting country specific regulations
Author global submissions for Class I-IV medical devices, and prescription drugs globally, which includes (but not limited to) US, European Union, and Canada
Complete required data entry into systems such as Health Canada, FDA FURLS, GUDID, and EUDAMED
Interpret and apply regulatory and quality requirements using a risk-based approach to enable effective decision-making and proposing solutions
Support internal and external audits; help facilitate federal drug and medical device inspections
Stay current on industry trends in relation to compliance regulations for drugs and medical devices
Create and update Quality Management System (QMS) procedures and processes that fall under Regulatory responsibility
Inform stakeholders of Corrective and Preventive Action (CAPA) and Supplier controls
Provide support to the QMS team through ongoing cross-training initiatives
Comply with Company and department policies and standards; performs other duties as assigned