Job Description : We are seeking a highly skilled and experienced Senior Regulatory Affairs Specialist to join our team. The ideal candidate will have a proven track record of authoring, managing, and receiving clearances for FDA 510(k) submissions. Must have a deep knowledge of regulatory requirements and processes for medical devices. This role will involve working closely with cross-functional teams to ensure compliance with regulatory standards, preparing regulatory submissions, and providing strategic regulatory guidance for new and existing products. Key Responsibilities : Lead the preparation, submission, and management of FDA 510(k) premarket notifications for medical devices. Prepare and review regulatory documentation to ensure compliance with FDA regulations and standards. Advise product development teams on regulatory requirements and strategy throughout the product lifecycle. Maintain up-to-date knowledge of FDA regulations, guidance documents, and industry best practices. Interface with FDA and other regulatory authorities to respond to inquiries and resolve regulatory issues. Ensure timely submission of regulatory filings, meeting project deadlines and milestones. Support internal audits and inspections related to regulatory compliance. Review labeling and promotional materials to ensure compliance with regulatory requirements. Develop and implement strategies for regulatory approvals in international markets, as needed. Qualifications : Bachelor's degree in Life Sciences, Engineering, or a related field. Minimum of 5-7 years of regulatory affairs experience in the medical device industry. Proven experience in authoring and managing FDA 510(k) submissions. 510(k) number will be requested to verify. Strong understanding of FDA regulations, including 21 CFR Part 820, 21 CFR Part 807, and related guidance. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in preparing responses to FDA queries and managing interactions with regulatory authorities. Ability to work independently and collaboratively in a cross-functional team environment. Preferred : RAC (Regulatory Affairs Certification) or similar professional certification. Experience with international regulatory submissions (e.g., CE marking, Health Canada). Show more Show less

We are seeking a detail-oriented, experienced, go-getter International Regulatory Specialist with a minimum of 3 years of hands-on experience supporting regulatory submissions and compliance initiatives in the medical device industry. Proven ability to navigate regulatory frameworks with a focus on U.S. FDA and Health Canada requirements. Adept at coordinating cross-functional activities, preparing regulatory files, and supporting product lifecycle activities from development through post-market. Strong emphasis in communication and collaboration skills, as well as ownership and accountability within a global cross-functional team. Key Responsibilities Own and support regulatory activities for international. Focus on U.S. FDA and Health Canada. Contribute to and maintain regulatory documentation including product regulatory files, IFUs, and labeling reviews. Collaborate with R&D, Quality and Business Unit teams to align regulatory documentation and submission content. Conduct regulatory impact assessments for design changes. Qualifications Bachelor of Science in Biomedical Engineering / Life Sciences / Related Field. Minimum of 3 years of regulatory experience in medical device industry. Proven experience contributing to regulatory filings. Strong understanding of international regulatory body regulations. Emphasis on U.S. FDA and Health Canada. Ability to interpret and apply regulatory requirements to complex technical issues. Excellent communication, organization, and problem-solving skills. Experience in supporting responses to regulatory agencies. Ability to work independently and collaboratively in a cross-functional team environment. Preferences Background in Quality Engineering, ensuring alignment between regulatory strategy and quality system requirements. Proven experience in contributing to international regulatory submissions. RAC (Regulatory Affairs Certification) or simliar professional certification Internal Auditor Training Show more Show less