Regulatory Affairs Manager
7 days ago
We are seeking a highly skilled Regulatory Affairs Manager to join our team at IntelliPro Group Inc. The successful candidate will be responsible for overseeing 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.
The Regulatory Affairs Manager will also support government interactions regarding device registrations, manage regulatory assessments for product changes, and ensure compliance with global regulatory requirements throughout the product lifecycle.
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.
- Collaborate 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 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 update regional regulatory 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 general and special controls for Class I and Class II devices, and premarket approval (PMA) for Class III devices.
- 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.
- Experience working with Class II devices subject to 510(k) submission and FDA's EUA 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.
IntelliPro Group Inc. is a global leader in talent acquisition and HR solutions, dedicated to delivering unparalleled service to clients, fostering employee growth, and building enduring partnerships.
We value diversity and do not discriminate based on race, color, religion, sex, sexual orientation, gender identity, national origin, age, genetic information, disability, or any other legally protected group status.
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