Full-Time Senior Regulatory Affairs Manager - Oncology

The Senior Regulatory Affairs Manager - Oncology will provide direct regulatory support for Oncology IVD/CDx products in all stages of the product lifecycle. This role will actively lead and support development and implementation of regulatory strategies, premarket submissions, post-market submissions, labeling review, interactions with regulatory bodies, and other related regulatory activities, primarily for the US market.

Responsibilities:

• Prepare and manage FDA submissions (PMAs, Q-Subs, IDEs, BDDs, SIRs, sPMAs, 30-Day notices, Annual Reports).
• Represent regulatory affairs in cross-functional project teams.
• Review project and submission documentation.
• Support regulatory activities throughout product lifecycle.
• Facilitate product approvals.
• Support regulatory strategic direction.
• Manage regulatory workflow and project deliverables.
• Oversee progress and completion of projects.
• Lead and coordinate responses to regulatory agencies.
• Identify project risk and develop mitigation plans.
• Provide strategic advice to the cross-functional team.
• Build and maintain a cooperative working environment.
• Provide updates on regulatory status and requirements.

Qualifications:

Bachelor’s degree in Life Sciences, Engineering, or related discipline with at least 7 years of relevant regulatory affairs experience in an IVD regulatory affairs role.

• Proven success in authoring and leading FDA regulatory submissions and interactions.
• Strong working knowledge of IVD/CDx and/or medical device development processes.
• Proven ability to independently manage the preparation and coordination of regulatory submissions.
• Successful track record of securing and maintaining product approvals.
• Awareness of regulatory issues and challenges associated with diagnostic and/or IVD/CDx development.
• Excellent analytical skills with high attention to detail.
• Strong written and verbal communication skills.
• Highly organized and capable of managing multiple priorities.
• Self-motivated and able to work independently and collaboratively.
• Hands-on, proactive, and solutions-oriented.
• Proficient with Microsoft Office, Propel, JIRA, Teams, Confluence, and AI tools is a plus.

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