Regulatory Affairs Manager

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

Responsibilities

• The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
• Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
• Support EU representatives in their creation of CE/IVD Technical Files
• Support global regulatory registration representatives for product registration activities
• Perform regulatory assessment of new and changed products.
• Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment.
• Participate in business meetings with potential new external partners.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.
• The delivery of regulatory guidance to project teams and external partners is a key activity that assists the company in achieving its business goals. The incumbent will serve as a member of the Global Regulatory department.
• Serve as the regulatory core team lead and provide active and ongoing regulatory guidance to project teams
• Responsible for providing guidance to ensure that all regulatory submissions are planned, communicated, and performed per regulatory and business requirements. In addition, this position serves as a subject matter expert on various regulations, coordinating regulatory issue resolution through the use of internal resources, regulatory agencies, and outside consultants as needed.
• Document regulatory strategies for product submissions.
• Facilitate and prepare U.S. regulatory Pre-Submission documents for Next Generation Sequencing and/or PCR assays
• Facilitate FDA pre-submission meetings
• Prepare U.S. regulatory submissions (PMA, PMA supplement, and 510(k)) for Next Generation Sequencing and/or PCR assays
• Support EU representatives in their creation of CE/IVD Technical Files
• Support global regulatory registration representatives for product registration activities
• Perform regulatory assessment of new and changed products.
• Stay on top of new or revised regulations, guidelines, points to consider, compliance guides, inspection reports, journals, meetings, etc.
• Conduct training and/or communicate appropriate materials, as needed, to improve the team's knowledge of working in a regulated environment.
• Participate in business meetings with potential new external partners.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.

Requirements

• B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science at least 5 years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA supplement submissions.
• Knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Ability to lead multiple projects and meet deadlines.
• Strong communication and teamwork skills.
• Capacity to communicate regulations to technical functions within the company.
• Experience as the RA representative on project core teams.