Regulatory Affairs Specialist

Regulatory Affairs Specialist

Responsibilities

• Support development activities for medical device software products.
• Develop regulatory strategies and prepare submissions for markets including the United States, European Union, and Canada.
• Collaborate with regional regulatory teams to align global regulatory strategies.
• Review and approve product labeling and promotional materials for software products.
• Represent Regulatory Affairs on cross-functional software development teams.
• Review and approve software documentation and determine regulatory submission requirements.
• Support additional regulatory projects and initiatives as needed.

Qualifications

• Knowledge of U.S. and international medical device regulations, including design controls, submission requirements, labeling regulations, promotional requirements, and quality systems.
• Experience with medical device software and understanding of software development lifecycle processes, IEC 62304, and software classification.
• Strong technical writing, editing, analytical, and problem-solving skills.
• Ability to work independently while collaborating effectively with cross-functional teams.
• Comfortable operating in a fast-paced environment with changing priorities.
• Strong organizational and communication skills.
• Experience with 510(k) submissions, Health Canada submissions, and/or EU MDR is preferred.

Education & Experience

• Bachelor's degree required.
• 2 to 5 years of Regulatory Affairs or related medical device industry experience.

Additional Information

• Remote/home office-based role.
• Approximately 5-15% travel required.
• Comprehensive benefits package and professional development opportunities available.