Regulatory Affairs Specialist

Role Overview

• 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