We are seeking a motivated and detail-oriented Regulatory Affairs Associate II to join our Regulatory Affairs team. In this role, you'll provide critical support in ensuring compliance with domestic and international regulations, preparing timely product submissions, and maintaining audit readiness across the business. You'll collaborate closely with cross-functional teams to guide product development, review technical documentation, and interact with regulatory authorities worldwide.
The Key Responsibilities
* Prepare, review, and support regulatory submissions for US, EU, and global markets.
* Review labelling, packaging, advertising, and promotional materials for regulatory compliance.
* Evaluate design/manufacturing changes and their impact on product registrations.
* Review technical protocols, reports, and documentation, ensuring accuracy and compliance.
* Provide regulatory guidance to product development teams on strategy, design, and compliance.
* Support the development and review of SOPs and maintain audit readiness.
* Respond to regulatory agencies and distributors, preparing documentation for marketing approvals.
* Prepare Certificates of Exportability, Certificates to Foreign Government (US FDA), and regulatory reports.
* Provide support during internal and external audits.
* Stay current with evolving global regulatory requirements and standards.
The successful candidate will possess;
* Bachelor's degree in science, engineering, or a related field and 3+ years' experience in medical device regulatory affairs, OR 5+ years' direct regulatory affairs experience without a degree.
* Strong knowledge of US and European regulatory processes; Class III experience preferred.
* Experience preparing regulatory submissions (IDEs, PMAs, 510(k)s, Design Dossiers/Technical Files).
* Solid understanding of Design Control (21 CFR 820) and quality system standards (ISO
* Strong written, verbal, and presentation skills, with excellent attention to detail.
* Skilled in Microsoft Office and highly organized, able to manage multiple priorities effectively.