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Regulatory Affairs Manager

Karwell Technologies

Richmond, IL

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JOB DETAILS
SKILLS
Assays, Bioengineering, Biology, Chemistry, Communication Skills, Current Good Manufacturing Practice (cGMP), FDA (Food and Drug Administration), Import/Export, Leadership, Multitasking, Next Generation Sequencing (NGS), People Management, Polymerase Chain Reaction (PCR), Problem Solving Skills, Regulations, Regulatory Submissions, Strategic Planning, Team Lead/Manager, Team Player, Time Management, Training/Teaching
LOCATION
Richmond, IL
POSTED
30+ days ago
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.
Requirements:
  • B.Sc. or equivalent experience in Biology, Chemistry, bioengineering, or related science.
  • At least 4+ 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.

About the Company

K

Karwell Technologies

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