Regulatory Consultant – Oncology Combination Device (Contract)

Location: Remote, US

Duration: 6-months 

Overview:
We are seeking an experienced Regulatory Consultant to support our CRO client on an oncology combination device project. The ideal candidate will have a strong background in oncology, combination products, and FDA regulations, including drug-device combinations. This is a contract role focused on ensuring compliance and assisting with regulatory submissions.

Key Responsibilities:

• Regulatory Strategy: Develop and implement regulatory strategies for the oncology combination device project, advising on FDA and international requirements.

• Submissions & Documentation: Lead preparation and filing of regulatory documents (e.g., IND, 510(k), PMA, Combination Product Designation Requests).

• Regulatory Liaison: Act as primary contact with regulatory agencies (FDA, EMA), attend meetings, and provide responses to queries.

• Compliance & Risk Management: Ensure compliance with FDA regulations, identify risks, and propose mitigation strategies.

• Collaboration: Work with cross-functional teams to ensure adherence to regulatory requirements in clinical trials and product development.

Qualifications:

• Experience: Minimum of 7+ years in regulatory affairs, with a focus on oncology and combination products (device + drug).

• Education: Bachelor’s degree in Life Sciences, Regulatory Affairs, or related field. RAC or similar certification is a plus.

• Skills: Strong knowledge of FDA regulations (21 CFR Part 4, 510(k), PMA), global regulations, and combination product submissions.

To Apply:
Submit your resume and cover letter outlining relevant experience.