Patterson Companies, Inc.

Regulatory Affairs Specialist

Patterson Companies, Inc.

full-time

Posted on:

Location Type: Hybrid

Location: ST PAUL • Minnesota • United States

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Salary

💰 $77,200 - $100,333 per year

About the role

  • Ensure comprehensive compliance with regulatory requirements throughout the entire product lifecycle — from initial development and manufacturing to distribution and post-market surveillance.
  • Ensure that products meet established standards for safety, efficacy, and quality.
  • Obtain and maintain regulatory approvals, supporting cross-functional teams, and ensuring alignment with applicable laws, regulations, and industry standards.
  • Author 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.
  • 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.
  • 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.

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
  • 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
  • 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
Benefits
  • Full Medical, Dental, and Vision benefits and an integrated Wellness Program
  • 401(k) Match Retirement Savings Plan
  • Paid Time Off (PTO)
  • Holiday Pay & Floating Holidays
  • Volunteer Time Off (VTO)
  • Educational Assistance Program
  • Full Paid Parental and Adoption Leave
  • LifeWorks (Employee Assistance Program)
  • Patterson Perks Program
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory complianceregulatory approvalsglobal submissionsdata entryrisk-based approachQuality Management System (QMS)Corrective and Preventive Action (CAPA)medical device regulationsISO 1348521 CFR Part 820
Soft Skills
teamworkcommunicationcustomer serviceorganizational skillsanalytical skillsproblem-solving skills