Regulatory Affairs Manager

Katalyst CRO; Charlotte (NC); On-site; USD 91,000 - 145,600; Full time

Job summary

A leading pharmaceutical company in Charlotte, NC, is seeking a Regulatory Affairs Manager to lead regulatory guidance and ensure compliance with U.S. and global regulations. The ideal candidate holds a B.Sc. in a relevant field with over 5 years in IVD Regulatory Affairs, possesses hands-on experience with submission processes such as 510(k) and PMA, and is adept in regulatory strategy development. This contract role offers an engaging environment with responsibilities across various regulatory tasks.

Qualifications

• 5+ years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA supplement submissions.
• Knowledge of regulatory strategy creation and cGMP/Quality Systems.

Responsibilities

• Provide regulatory guidance to project teams and external partners.
• Serve as regulatory core team lead.
• Ensure regulatory submissions are planned and performed correctly.
• Prepare U.S. regulatory submissions for Next Generation Sequencing and/or PCR assays.
• Conduct training to improve knowledge of compliance.

Skills

Project management

Regulatory guidance

Strong communication

Teamwork

Education

B.Sc. in Biology, Chemistry, bioengineering, or related science

Job description

Join us at Katalyst CRO as a Regulatory Affairs Manager in Charlotte, NC.

Salary: $91,000.00 - $145,600.00 (3 days ago).

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 ensuring all regulatory submissions are planned, communicated, and performed per regulatory and business requirements; serve as a subject matter expert, coordinate regulatory issue resolution.
• 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 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 with 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.

Seniority Level

Mid‑Senior level

Employment Type

Contract

Job Function

Legal

Industries

Pharmaceutical Manufacturing