Regulatory Affairs Manager

cGxPServe; Gurnee (IL); On-site; USD 80,000 - 110,000; Full time

Job summary

An established industry player is seeking a Regulatory Affairs Specialist to provide expert guidance on regulatory submissions and compliance. This role is pivotal in ensuring that all regulatory activities align with business objectives and regulatory requirements. The incumbent will lead regulatory core teams, prepare essential documentation for U.S. submissions, and support global registration efforts. The position requires strong communication skills and a deep understanding of regulatory frameworks, making it an exciting opportunity for those passionate about ensuring product compliance in a dynamic environment.

Qualifications

• 5+ years of IVD Regulatory Affairs experience.
• Hands-on experience with 510(k), PMA, and PMA supplement submissions.

Responsibilities

• Provide regulatory guidance to project teams and external partners.
• Document regulatory strategies for product submissions.
• Prepare U.S. regulatory submissions for Next Generation Sequencing.

Skills

Regulatory Affairs

Communication Skills

Project Management

Knowledge of cGMP/Quality Systems

Teamwork

Education

B.Sc. in Biology

B.Sc. in Chemistry

B.Sc. in Bioengineering

Tools

Regulatory Submission Software

Job description

Responsibilities:

• 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.
• 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.
• 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.
• Assist the Regulatory department in updating, improving, and crafting internal policies and procedures.
• Participate in business meetings with potential new external partners.

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.
• Deep knowledge of regulatory strategy creation, design control, cGMP/Quality Systems, and import/export requirements.
• Experience as the RA representative on project core teams.
• Strong communication and teamwork skills.
• Ability to lead multiple projects and meet deadlines.
• Capacity to communicate regulations to technical functions within the company.