About the position
The Principal Regulatory Affairs Specialist at MedAlliance plays a critical role in the development and submission of PMA modules for Class III combination products. This position requires a strong background in regulatory affairs within the medical device industry, focusing on compliance with FDA regulations and collaboration with cross-functional teams to support product development. The role is essential for ensuring that the company's innovative medical solutions meet regulatory standards and contribute to improving healthcare outcomes.
Responsibilities
• Lead regulatory strategy development and execution for PMA submissions, ensuring compliance with FDA regulations and guidance.
• Collaborate cross-functionally with R&D, Quality Assurance, and Clinical teams to support the development of combination products and medical devices.
• Prepare and submit regulatory documents, including PMA applications, with emphasis on clinical module.
• Direct and support interactions with regulatory agencies and provide timely responses to inquiries.
• Stay current on industry trends, regulatory changes, and best practices to inform company strategy and ensure compliance.
• Provide training and guidance to junior regulatory staff on regulatory requirements and processes.
• Develop and maintain regulatory affairs policies and procedures to enhance operational efficiency.
• Help manage FDA IDE/PMA clinical reports/modules and post-approval clinical study activities and be involved in clinical evaluation processes.
• Interpret clinical evidence in the context of applicable regulations, standards, and guidelines (e.g., FDA guidance, MEDDEV 2.7/1, MDR).
• Support literature reviews and research to stay abreast of industry trends, competitor products, and emerging technologies.
Requirements
• Bachelor's degree in Life Sciences, Engineering, or a related field; advanced degree preferred.
• 8-10 years of experience in regulatory affairs within the medical device industry, with a strong focus on PMA submissions.
• In-depth knowledge and understanding of FDA submissions for IDE and PMA process.
• Previous experience with authoring clinical modules for FDA submissions.
• Knowledge and understanding of clinical evaluation documentation to MEDDEV 2.7/1 guidelines.
• Previous experience in medical writing, preferably within the device-drug combination devices.
• Previous experience in Post Market Surveillance activities (PMS) and Post Market Clinical Follow-up activities (PMCF).
• Expert knowledge of regulatory requirements and guidance documents for medical devices with FDA regulations (e.g., IDE, PMA) and familiarity with international standards (e.g., ISO 13485, EU MDR, MEDDEV 2.7/1, ISO14155, MDCG).
• Excellent communication, negotiation, and interpersonal skills.
• Strong analytical and problem-solving abilities, with a proactive approach to regulatory challenges.
• Ability to work independently and as part of a team in a fast-paced environment.
Nice-to-haves
• Experience with combination products is highly desirable.
• Experience in clinical research is highly desirable.
Benefits
• 401(k)
• Medical, Dental and Vision Insurance
• Life insurance
• Paid time off
Apply Now
Apply Now