Clinical Regulatory Affairs Manager

Job Details:

Clinical Regulatory Affairs Manager

An innovative technology company is seeking an experienced Clinical Regulatory Affairs Manager to support regulatory strategy, clinical initiatives, and product development activities for advanced healthcare technologies.

This role offers the opportunity to work with cross-functional teams to help bring cutting-edge medical technologies to market while ensuring compliance with regulatory requirements and supporting the generation of clinical evidence throughout the product lifecycle.

What You'll Do:

• Lead regulatory planning for new product launches and product enhancements.
• Prepare documentation required for submissions to U.S. and international regulatory authorities.
• Provide regulatory guidance during software development, product design, and verification activities.
• Partner with engineering, quality, and product teams to ensure compliance requirements are incorporated throughout development.
• Coordinate activities supporting clinical evaluations, investigator collaborations, and research initiatives.
• Review product changes for regulatory impact and recommend appropriate submission pathways.
• Contribute to risk management, technical documentation, and product lifecycle compliance.
• Monitor evolving regulations affecting software-based medical devices and communicate business impacts.
• Support interactions with regulatory agencies, consultants, research institutions, and healthcare partners.
• Manage multiple projects while maintaining timelines and quality standards.

The ideal candidate will have:

• Bachelor's degree in Engineering, Biomedical Engineering, Life Sciences, Regulatory Affairs, or a related field.
• Five or more years of experience in medical device regulatory affairs.
• Experience preparing FDA medical device submissions.
• Knowledge of software-based medical devices, digital health technologies, AI-enabled products, medical imaging, or related healthcare technologies.
• Familiarity with international regulatory frameworks and medical device quality systems.
• Experience collaborating with engineering teams during product development.
• Strong technical writing, communication, and project management skills.
• Experience supporting clinical studies, research programs, or healthcare collaborations is preferred.

Why Join?

This is an excellent opportunity to contribute to the development of innovative healthcare technologies within a collaborative and fast-paced environment. You'll work alongside multidisciplinary teams and play an important role in bringing new medical technologies to market while supporting continued product innovation.

Compensation & Benefits

• Competitive base salary based on experience.
• Performance-based incentive opportunities.
• Medical, dental, and vision insurance.
• 401(k) retirement savings plan.
• Flexible spending accounts.
• Paid vacation and company holidays.

To apply, email [email protected] your resume.

Sheila Shamloo
[email protected]

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