Meridian Bioscience Inc.

Regulatory Affairs Principal

Meridian Bioscience Inc.

full-time

Posted on:

Location Type: Remote

Location: United States

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Job Level

Lead

About the role

  • Responsible for managing tasks/processes and providing expert guidance on activities related to the design, development, and clearance of new products and product modifications.
  • Will ensure that new products and documentation related to new product design, development, transfer, validation/verification, labeling, and regulatory submissions are compliant with applicable quality and regulatory requirements.
  • Serves as the department expert and advisor on specialized activities such as Pre-Submissions, 510(k) submissions, PMAs, combination device applications and post-clearance activities and projects.
  • Provide guidance and participate in drafting of regulatory submissions for domestic, world-wide commercialization and other business objectives.
  • Authors and reviews technical protocols and data in support of clinical trials, validation, verification and regulatory submissions.
  • Provides guidance and participates in evaluation of the regulatory impact of changes associated with product design changes and routine modifications to cleared products.
  • Reviews, and helps provide guidance for product labeling, including Instructions for Use (IFU/PI), to ensure adherence to applicable regulations and standards.
  • Provides guidance and participates in implementation of new regulations and standards.
  • Conducts training of new employees, reviews training documentation for co-workers to ensure compliance to regulations.
  • Other duties as assigned.

Requirements

  • Bachelor of Science degree in Biology, Biochemistry, Microbiology, Regulatory Affairs or related field.
  • At least 7 years of experience in the medical devices industry;
  • At least 7 years’ experience supporting medical device regulatory submissions (e.g., 510(k)s and/or PMAs);
  • Proven experience with application of quality and regulatory requirements in the design and development of medical devices.
  • Professional certification (RAC/ASQ) required.
  • Demonstrated success in achieving FDA and other regulatory agency approvals and clearances.
  • Demonstrated knowledge of FDA regulations, In Vitro Device Directive and other national and international regulations and standards.
  • Ability to work independently and identify and/or resolve quality issues/discrepancies with others in a proactive, diplomatic, flexible and constructive manner.
  • Understanding of FDA, EU, MDSAP and ISO standards applicable to the department and consequences of non-conformance.
  • Computer proficiency required, including Word, Excel and database management.
  • General knowledge of statistical analysis.
Benefits
  • Health insurance
  • 401(k) matching
  • Flexible work hours
  • Paid time off
  • Remote work options
Applicant Tracking System Keywords

Tip: use these terms in your resume and cover letter to boost ATS matches.

Hard Skills & Tools
regulatory submissions510(k)PMAquality requirementsclinical trialsvalidationverificationstatistical analysisproduct designlabeling
Soft Skills
guidancetrainingindependent workproblem-solvingdiplomacyflexibilityconstructive feedbackcommunicationcollaborationevaluation
Certifications
RACASQ