Regulatory Compliance Specialist

JOB SUMMARY

The Regulatory Compliance Specialist will be responsible for management of the Internal Audit, CAPA, Complaint Management, and Supplier Management processes. The Specialist will provide Quality System expertise to the Company being knowledgeable in the US FDA Quality System Requirements (QSR, 21CFR820 and associated regulations), ISO 13485 and CMDCAS requirements as well as associated ISO, ANSI and regulatory guidance documents. Specialist will also manage all controlled environment monitoring, product bioburden, and LAL testing.

ESSENTIAL DUTIES & RESPONSIBILITIES

  • Follows all procedures and Company policies insuring that regulatory requirements are achieved in an ethical manner.
  • Meets commitments on time with accuracy and attention to detail.
  • Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents. Provide interpretive assistance to all departments regarding these documents.
  • Supports management of external and customer audits providing technical expertise in processes and documentation.
  • Develop and manage Quality metrics and monthly Quality Report, ensuring metrics are accurate and posted in a timely manner.
  • Manages Internal Audit program
  • Establishes and publishes annual schedule and ensures audits are conducted in accordance with the schedule
  • Publishes updates to schedule as needed
  • Identifies, trains and supports internal auditors
  • Conducts audits and publishes audit reports and closures
  • Facilitates corrective actions associated with the internal audit program
  • Establishes, monitors and publishes metrics associated with the CAPA process
  • Manages CAPA process
  • Conducts failure investigations to determine root cause and appropriate corrective or preventive actions
  • Ensures documentation associated with CAPA is adequate and completed in a timely manner
  • Establishes, monitors and publishes metrics associated with the CAPA process
  • Coordinates activities between MN and MX facilities
  • Manages Complaint process and customer issued SCARs
  • Maintains Customer Complaint and SCAR log, files and metrics.
  • Conducts investigations into complaints/SCARs and facilitates corrective actions associated with complaint/SCAR resolution.
  • Prepares customer communications summarizing investigational findings and actions taken.
  • Coordinates activities and conducts meetings between MN and MX facilities to ensure timely responses to complaints/SCARs.
  • Manages Supplier Management process
  • Ensures audits are conducted in accordance with the annual Supplier Audit Schedule
  • Conducts supplier audits and publishes audit reports and closures.
  • Monitors supplier performance and publishes supplier score cards as required.
  • Issues Supplier requests for Corrective actions (SCARs) and ensures that appropriate responses and closures are obtained in a timely manner.
  • Manages Environmental Monitoring in MN facility
  • Schedules suppliers who conduct the monitoring and escorts while on site
  • Reviews and publishes the reports relative to monitoring
  • Establishes, monitors and publishes metrics associated with monitoring program
  • Manages Product testing (bioburden, LAL) for Micromedics and Customer products
  • Schedules samples and testing
  • Reviews, summarizes and publishes results of the testing
  • Conducts training for Quality System related procedures and compliance issues.

EDUCATION & EXPERIENCE REQUIREMENTS

  • Bachelor’s degree in engineering or related discipline is required (Microbiology is highly valued)
  • Minimum three years’ experience in Regulatory Affairs/compliance, in a medical device company
  • Good working knowledge of FDA Quality System Regulation (QSR), ISO 13485, and CMDCAS requirements.
  • Experienced with Microsoft Office Suite (Outlook, Word, Excel, PowerPoint)

SKILLS & ABILITIES

  • Fluency in Spanish strongly desired
  • Excellent written and verbal communication skills
  • Ability to generate reports using data analysis, SPC analysis/tools, etc. and effectively communicate findings/proposals to various users inside and outside the organization.
  • Ability to effectively present information to senior managers and other employees of the organization.
  • Ability to solve practical problems and deal with a variety of concrete variables and ability to interpret a variety of instructions furnished in written and oral form.
  • Strong interpersonal skills to work across international organization
  • Establishes and cultivates communication and network of support to facilitate completion of assignments
  • Demonstrates critical thinking and problem solving skills
  • Exercises judgment in selecting innovative, practical methods to achieve problem resolution
  • Ability to manage multiple priorities
  • Good planning and organizational skills
  • Team oriented, ability to work in a small team, as well as independently

WORKING CONDITIONS & PHYSICAL DEMANDS

Office environment. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed above are representative of the knowledge, skill, and/or ability required. Reasonable accommodation may be made to enable individuals with disabilities to perform the essential functions.

TRAVEL REQUIRED

Estimated 10%

Nordson Corporation provides equal employment opportunity to all applicants and employees. No person is to be discriminated against in any aspect of the employment relationship due to race, religion, color, sex, age, national origin, ancestry, disability, sexual orientation, gender identity, genetic information, citizenship status, marital status, pregnancy, veteran status or any other status protected by applicable federal, state, or local law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check, consistent with applicable laws.


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