Global Regulatory Submissions Lead

Katalyst CRO; Charlotte (NC); On-site; USD 120,000 - 180,000; Full time

Job summary

Katalyst CRO is seeking a Regulatory Affairs professional to lead regulatory guidance for project teams and external partners in a fast-paced, global setting. You will coordinate submissions, engage with FDA and EU authorities, and mentor junior staff within the Global Regulatory department.

The role requires at least 5 years in IVD Regulatory Affairs, expertise in 510(k) and PMA submissions, and strong communication skills to navigate cross-functional teams.

Qualifications

• B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science (at least 5 years of IVD Regulatory Affairs).
• Experience with 510(k), PMA, and PMA supplements.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.

Responsibilities

• Deliver regulatory guidance to project teams and external partners as part of Global Regulatory.
• Lead regulatory core team and provide ongoing guidance to projects.
• Ensure regulatory submissions are planned, communicated, and performed per requirements; coordinate resolutions with regulators and consultants.

Skills

Regulatory guidance

Regulatory submissions

Regulatory strategy

Project leadership

Regulatory communications

Education

B.Sc. or equivalent in Biology/related science

Job description

Katalyst CRO is seeking a Regulatory Affairs professional to lead regulatory guidance for project teams and external partners in a fast-paced, global setting. You will coordinate submissions, engage with FDA and EU authorities, and mentor junior staff within the Global Regulatory department.

The role requires at least 5 years in IVD Regulatory Affairs, expertise in 510(k) and PMA submissions, and strong communication skills to navigate cross-functional teams.