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.
FAQs
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