What are the responsibilities and job description for the Regulatory Affairs Specialist position at Extension, Inc?
Regulatory Affairs & Quality Systems Specialist
Position Overview
A growing medical technology organization is seeking a Regulatory Affairs & Quality Systems Specialist to support regulatory compliance, quality system initiatives, and product lifecycle activities for software-based healthcare products. This individual will play a key role in maintaining regulatory approvals, supporting quality management processes, and ensuring compliance with applicable domestic and international medical device regulations.
This position is ideal for someone who enjoys working at the intersection of regulatory affairs, quality systems, and product development within a highly regulated environment.
Key Responsibilities
Regulatory Affairs
- Support preparation, submission, and maintenance of regulatory filings, including FDA 510(k) submissions and related documentation.
- Maintain technical files, design documentation, and regulatory records throughout the product lifecycle.
- Assist with regulatory strategy development for global markets, including the United States, European Union, and United Kingdom.
- Provide guidance regarding product claims, labeling, intended use statements, and marketing considerations.
- Monitor changes to applicable regulations, standards, and guidance documents and communicate potential business impacts.
- Participate in regulatory assessments related to product modifications, software updates, and design changes.
Quality Systems
- Support and maintain the Quality Management System (QMS) to ensure ongoing compliance with regulatory and industry requirements.
- Participate in internal audits, corrective and preventive action (CAPA) activities, complaint investigations, and post-market quality initiatives.
- Assist with risk management, quality documentation, and continuous improvement activities.
- Support field actions, quality investigations, and corrective action implementation when necessary.
- Ensure quality processes align with applicable standards and regulatory expectations.
Product Development & Lifecycle Support
- Collaborate with engineering, product development, clinical, and quality teams throughout development and release activities.
- Conduct regulatory and quality impact assessments for product changes and software releases.
- Provide guidance related to software lifecycle processes, usability considerations, risk management activities, and cybersecurity-related compliance requirements.
- Support design control activities and documentation throughout development and commercialization efforts.
Qualifications
Required
- Bachelor's degree in Engineering, Life Sciences, Regulatory Affairs, Quality, or a related technical discipline.
- 5 years of Regulatory Affairs and/or Quality Systems experience within the medical device, healthcare technology, or software-regulated industry.
- Experience supporting FDA submissions, including 510(k) filings.
- Strong understanding of FDA quality system requirements, ISO 13485, risk management principles, and software development compliance standards.
- Demonstrated ability to interpret and apply regulatory requirements in a practical business environment.
- Strong communication skills with the ability to collaborate across technical and non-technical teams.
- Proven ability to manage multiple priorities independently within a fast-paced environment.
Preferred
- Experience supporting Software as a Medical Device (SaMD) products.
- Familiarity with medical imaging, diagnostic software, healthcare IT, or clinical workflow applications.
- Experience supporting EU MDR regulatory activities and technical documentation.
- Knowledge of software lifecycle standards, usability engineering principles, and cybersecurity considerations for regulated products.
- Experience working in cross-functional product development environments.