Regulatory Affairs And Quality Assurance - Contractor

Meridian Bioscience, Inc North Billerica , MA 01862

Posted 2 months ago

About Meridian

Meridian Bioscience is a fully integrated life science company that develops, manufactures, markets and distributes a broad range of innovative diagnostic products. We are dedicated to developing and delivering better solutions that give answers with speed, accuracy and simplicity that are redefining the possibilities of life from discovery to diagnosis. We are looking for talented and passionate individuals that help drive our vision. Our innovative culture will allow interested candidates to discover and create, through collaboration, cutting edge solutions to tough problems.

Job Summary

Responsible for supporting post market regulatory activities regarding complaint analysis, MDR submissions, post market risk assessments (HHA), supports maintenance of the product technical file in support of CE Marking, and risk management file updates. Also leads field safety corrective actions/recalls, as required. Serves as a liaison between quality assurance and manufacturing, research and development, customer service and customers regarding complaint investigations, the identification of root cause and the recommendation/coordination of corrective/preventative action(s), when required.

Key Duties

  • Receive, review and conduct investigations of escalated product complaints or assigned product quality issues, from data collection to investigation summary, including coordinating implementation or recommendation of follow-on quality system activities.

  • Examine complaint data to determine trends that may result in corrective action, report complaint trends to management and assist in post market compliance activities, including field safety corrective actions/recalls related to complaints.

  • Work independently and/or cross functionally with various departments (e.g. sales, marketing, customer service, R&D, manufacturing), as well as complainant, to collaborate, gather and evaluate details of the technical investigation information to effectively establish the cause of the quality issue and ensure a clear, concise and complete investigation is conducted.

  • Applies knowledge of device regulatory requirements (FDA and/or other International Regulatory Agencies) to support the Post Market Surveillance MDR/ADE reporting process and evaluates complaints for MDR reporting utilizing product knowledge and Decision Trees. Processes basic submissions of MDR/ADE; develops and reviews complex MDR/ADE submissions with assistance from QA Management.

  • Lead post market risk assessment process and escalate critical issues for field action determination. Facilitate and manage the recall process when necessary.

  • Provide support to R&D in the ongoing maintenance of product Technical Files that support CE mark.

  • Review and analyse lot documentation (DHRs) to determine if there are any anomalies that maybe related to reported product failures.

Qualifications

Knowledge, Skills and Abilities:

  • Understanding of regulatory obligations for compliance within the scope of the department (21 CFR 820, 803, 806; ISO 13485).

  • Solid understanding and experience with CE marking, technical files and product registration requirements (domestic and international)

  • Strong knowledge of post-market regulatory compliance requirements

  • Reasoning ability, support and prioritize projects - appropriately judging priorities, adapt to shifting priorities, work with minimal supervision, able to resolve problems/conflicts independently.

  • Able to make decisions quickly using information at hand and evaluate the need to obtain clarification and direction when necessary.

  • Inquisitive and problem-solving mindset.

  • Exceptional organizational skills, including time management.

  • Strong interpersonal skills; ability to lead teams and facilitate team meetings

  • Effective communication skills, including verbal and technical writing skills

  • Knowledge based computer skills, such as MS office, outlook and excel

Education and Experience:

  • Bachelor's Degree required, preferably in a scientific, healthcare, nursing, clinical laboratory or related field.

  • At least 5 years' experience in regulated health/device industry. Exposure to medical device quality system regulations and understanding of device safety requirements required.

  • Prior experience processing medical device or drug complaints.

We are proud to be an EEO/AA employer Minority/Female/Disability/Veteran. We maintain a drug-free workplace and perform pre-employment substance abuse testing.


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Regulatory Affairs And Quality Assurance - Contractor

Meridian Bioscience, Inc