Regulatory Affairs Specialist
4 weeks ago
IntelliPro Group Inc. is seeking a highly skilled Regulatory Affairs Specialist to oversee medical device development and market introduction, ensuring compliance with regulatory standards for Class I, II, and III devices.
This role involves collaborating with cross-functional teams to conduct regulatory pre- and post-market analyses, preparing submissions for FDA 510(k) and EUA applications, and maintaining an ISO 13485-compliant Quality Management System.
Key Responsibilities- Lead the regulatory team in ensuring proper oversight of medical device development and market introduction, including Class I, Class II, and Class III devices.
- Work closely with Quality, Engineering, Product Management, Marketing, and Sales teams to perform regulatory pre- and post-market analysis and implement and maintain an ISO 13485 and FDA-compliant Quality Management System.
- Participate in the preparation and review of regulatory submissions to the US FDA, including 510(k) and EUA applications, and international (outside the US) regulatory authorities.
- Support government interactions pertaining to medical device registrations and licensing for Class II devices (e.g., blood pressure monitors, and glucose meters) and Class III devices (e.g., pacemakers, and heart valves).
- Develop and implement regional regulatory strategies and update strategies based on regulatory changes.
- Provide regulatory support to cross-functional product development and project teams throughout the product lifecycle.
- Ensure compliance with FDA and global regulatory requirements, including the general and special controls for Class I and Class II devices, and premarket approval (PMA) for Class III devices.
- Support regulatory activities required for MDR compliance.
- Provide regulatory assessment for manufacturing and design changes.
- Provide regulatory review and approval of change order packets.
- Support product regulatory intelligence and risk assessments.
- Assist in maintaining compliance with product post-market requirements.
- Support post-market regulatory actions taken for the products.
- Assist in the review of advertising and promotional materials.
- Support internal and external audits.
- Ensure compliance with internal procedures and external regulations and standards.
- Maintain and update quality system procedures.
- Maintain quality records and other controlled documents.
- Other Regulatory and Quality duties as assigned.
- Hands-on experience managing the entire 510(k) submission process for Class II devices is required.
- Experience in working with the FDA's Emergency Use Authorization (EUA) is desired.
- Bachelor's degree in Science, Engineering, Math, a medical field, or an equivalent educational background with a focus on technical writing, scientific methodologies, and problem-solving.
- A minimum of 5 years of experience in medical device Regulatory Affairs, showcasing a comprehensive understanding of regulatory frameworks.
- processes, as well as familiarity with Class I general controls and Class III PMA processes.
- Demonstrated ability to manage small projects, displaying exceptional organization, independence, and outcome-driven focus.
- Outstanding analytical and communication skills, paired with a strong sense of teamwork and meticulous attention to detail.
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