Regulatory Affairs Specialist

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).

Essential Functions

• 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

Minimum 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

Preferred Requirements

• Experience with Health Canada regulated environment

Skills and Abilities

• 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

Physical and Cognitive Demands

• Communicate/Hearing Frequently

• Communicate/Talking Frequently

• Learn New Tasks or Concepts Frequently

• Make Timely Decisions in the Context of a Workflow Frequently

• Complete Tasks Independently Constantly

• Maintain Focus Constantly

• Remember Processes & Procedures Constantly

• Stationary Position (Seated) Constantly

• Vision Constantly

The potential compensation range for this role is below. The final offer amount would be based on various factors such as candidate location (geographical labor market), experience, and skills. $77,200.00 - $94,500.00