Job Description

This position is listed on behalf of a partner company, who manages all applications and next steps. Our partner is looking for a Senior Regulatory Affairs Specialist based in the United States. The Senior Regulatory Affairs Specialist will play a key role in supporting the regulatory strategy and market access of medical devices and in vitro diagnostic (IVD) products across U. S. and international markets. You will prepare and manage regulatory submissions for new and modified products, while guiding product development teams on applicable requirements. The role combines regulatory strategy, clinical study oversight, risk assessment, and direct interaction with regulatory agencies. You will collaborate cross-functionally to ensure products and supporting documentation meet applicable regulatory standards throughout development and commercialization. Your expertise will help shape regulatory pathways, address agency requests, and support successful product approvals and continued market access. This is a remote opportunity for an experienced regulatory professional who enjoys working across technical, clinical, quality, and business functions. Accountabilities: - Interpret and apply U. S. and international regulatory requirements for medical devices and IVD products, providing guidance to product development teams throughout the development process. - Develop regulatory strategies and provide assessments of regulatory risks, options, and appropriate pathways for new and modified products. - Prepare and manage U. S. regulatory submissions, including 510(k)s, PMA applications and supplements, Product Development Protocols (PDP), Investigational Device Exemptions (IDE), Pre-Submissions, and related supplements. - Coordinate information and documentation required for international product registrations and licensing activities.

- Interact and negotiate with U. S. regulatory agencies and coordinate responses to additional data or information requests. - Review clinical protocols and monitor clinical studies to ensure appropriate data is collected to support regulatory submissions. - Analyze clinical study results in the context of regulatory requirements and recommend appropriate courses of action. - Participate in the development and review of product release documentation, labels, labeling, and promotional materials to ensure regulatory compliance. - Provide regulatory opinions and guidance related to premarket requirements, exports, labeling, and other applicable regulatory matters. - Maintain required privacy, security, compliance, and regulatory training, including requirements related to occasional access to protected health information (PHI). Requirements - Bachelor’s degree or equivalent; a degree in biological sciences, chemistry, or a related scientific discipline is strongly preferred. - At least 5 years of experience in the medical device, diagnostic, biologic, and/or pharmaceutical industry, preferably within regulatory affairs or a closely related function. - Current knowledge of U. S. medical device and IVD regulatory requirements, including Good Laboratory Practices (GLP) and Quality System Regulations (QSR). - Familiarity with European medical device and IVD regulatory requirements and applicable European quality system standards. - Strong written and verbal communication skills, with the ability to effectively collaborate with stakeholders at different organizational levels as well as external regulatory contacts. - Strong organizational skills and the ability to manage multiple priorities in a regulated, cross-functional environment. - Project management experience is desirable, particularly experience coordinating regulatory activities across product development and clinical teams. Benefits - Remote position available across the United States.

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