Staff Specialist, Regulatory Affairs

This is a fully remote position, open to applicants in Canada.

📋 Description

• Report directly to the Senior Manager of Regulatory Affairs.

• Provide support for MMS Dispensing products, which include non-Medical and Medical Devices, associated Software, and Accessories, on a global scale from a Regulatory Affairs perspective.

• Formulate and implement a global regulatory strategy for new product development, maintenance, and end-of-life processes.

• Stay updated on and interpret existing and emerging regulatory requirements and international standards for the U.S. and other global markets.

• Lead regulatory initiatives to ensure compliance with both new and existing regulations, including FDA Medical Device Regulations and EU-MDR.

• Address and escalate regulatory and compliance challenges to senior management as needed.

• Maintain effective communication and provide prompt responses to internal stakeholders.

• Promote continuous improvement in internal processes and enhance customer satisfaction.

• Identify, nurture, and mentor high-performing regulatory professionals.

• Ensure that QSMR requirements are consistently followed and executed from a Regulatory Affairs viewpoint.

• Collaborate with cross-functional teams to create and remediate Technical Files.

• Prepare and implement thorough regulatory impact assessments for design-control modifications to existing products.

• Undertake additional duties and assignments as necessary.

⛳️ Requirements

• Bachelor’s degree in biology, engineering, or another science-related field is required.

• A minimum of 5–7 years of relevant experience in Regulatory Affairs within the medical device sector is required.

• A strong focus on Software as a Medical Device (SaMD) is preferred.

• RAPS RAC certification is preferred.

• Familiarity with Regulatory and Quality Information Management systems such as SAP, RIM, or similar platforms.

• Proficient in digital tools including MS Word, Excel, PowerPoint, and Teams.

• Experience in Project Management.

• Excellent verbal and written communication abilities, with a keen attention to detail.

• Strong skills in organization, project management, and submission oversight.

• Capability to prioritize multiple tasks and meet conflicting deadlines.

• Strong teamwork and collaboration skills.

• Ability to lead and influence without direct authority.

• Proficient in developing regulatory strategies.

• Adaptable and flexible, with the ability to effectively respond to evolving business priorities.

• Possess functional and technical knowledge with a proven track record of achieving goals successfully.

🏝️ Benefits

• Comprehensive Total Rewards program.

• Opportunities for rewards and recognition.

• Competitive compensation and benefits package.

• Consideration for workplace accommodations in accordance with applicable law.

• This position offers a remote work arrangement.

• Employer recognizes the importance of a flexible work-life balance.