Quality Assurance and Regulatory Affairs Specialist

Sampled; Piscataway Township (NJ); On-site; USD 40,000 - 300,000; Full time

Job summary

A leading company in biotechnology seeks a Quality Assurance and Regulatory Affairs Specialist to support regulatory submissions and maintain compliance in a clinical laboratory setting. This mid-senior level position demands expertise in regulatory standards and a proactive approach to quality assurance in human health advancement.

Qualifications

• Expertise in clinical assays and regulatory environment.
• 4+ years in quality assurance or regulatory affairs.
• Strong knowledge of US and OUS regulatory requirements.

Responsibilities

• Assist with regulatory submissions at state and federal levels.
• Track Quality Indicators and participate in audits.
• Maintain licenses and accreditations.

Skills

Attention to detail

Excellent written communication

Analytical skills

Interpersonal skills

Ability to work under pressure

Education

Bachelor’s degree in chemistry or scientific discipline

Job description

Quality Assurance and Regulatory Affairs Specialist

Quality Assurance and Regulatory Affairs Specialist

1 week ago Be among the first 25 applicants

Company Overview

Sampled enables clients to advance human health by leveraging active biological samples through; preservation, immortalization and utilization in comprehensive multiomics research within the leading-edge Global Integrated Analytical Biorepository.

Company Overview

Sampled enables clients to advance human health by leveraging active biological samples through; preservation, immortalization and utilization in comprehensive multiomics research within the leading-edge Global Integrated Analytical Biorepository.



Sampled is committed to building a sustainable, inclusive and diverse culture where team members enjoy equal opportunities in a safe, supportive and empowering environment. Sampled believes that as an organisation we have a duty to be actively engaged in supporting not just the clients and industries we serve but the communities where we live and work.



Position Summary

As our Quality Assurance and Regulatory Affairs Specialist, you will assist in all activities and administrative duties regarding Sampled Licensure and Accreditation. This includes preparing and supporting regulatory submissions at the state and federal levels.

This role involves tracking Quality Indicators, Inspection Readiness – State, Federal, CAP, Training Records, Competencies, Proficiency Testing, participate in Audits, and Audit Readiness Walkthroughs.

Responsibilities

Apply working knowledge of applicable regulations and standards (e.g. ISO, FDA, CAP, CLIA, GMP, GCP, GLP, GCLP, ICH, and other global standards) to provide regulatory guidance and support development of global regulatory strategies for a clinical laboratory.

Prepare regulatory submission documents for the FDA or other regulatory agencies (e.g., 510(k), PMA, NY DOH, NJ DOH) by working closely with project teams to implement design control, risk management, or other applicable principles to the regulatory submission processes/documents.

Maintain state and federal Licenses, and all applicable accreditations and ensuring licensures are kept up to date.

Demonstrate a working knowledge of Good Documentation Practice, Good Clinical Practice, and Good Laboratory Practice.

Demonstrate a working knowledge of design change control.

Support and participate in audits and inspections of the company by sponsors and regulatory authorities and clients.

Support QMS Processes.

Coordinate communication methods (meetings, presentations, documentation) to drive the timely closure of issues.

Lead monthly meetings related to CAP Biorepository and Clinical compliance, maintain and distribute these Meeting Minutes.

Through These Monthly Meetings

Develop and maintain mechanisms to track and trend regulatory compliance.

Develop and monitor Laboratory KPIs.

Ensure that all Quality Indicators are being monitored, training records/competencies are current, and Proficiency Testing is being implemented on time.

Confirm that lab managers are maintaining all Equipment logbooks, maintenance, and validation activities.

Drive completion of internal audits in accordance with the audit schedule.

Be an effective team player, with behaviors reflecting the Sampled Values: Strive to delight our clients, move innovation forward, Accelerate your business, Rise together as a team, Transcend what is possible.

Support Regulatory Affairs and Quality Assurance management, as needed.

All other duties as assigned.

Position Requirements

Bachelor’s degree in chemistry, scientific or engineering discipline

Must possess expertise and knowledge of clinical assays, LDTs and medical devices in a regulated environment.

4+ years of work experience in quality assurance and/or regulatory affairs in medical device, biotech, life sciences or pharmaceutical industry

Attention to detail, ensuring documentation is complete, accurate, and submitted on time.

Excellent knowledge and experience with global US and OUS regulatory requirements.

Ability to identify, research, analyze technical documentation, and interpret governmental regulations.

Excellent verbal and written communication skills.

Effective interpersonal and cross-functional collaboration skills.

Experience serving as a regulatory liaison and working in cross-functional team.

Capable of handling multiple tasks/projects and managing priorities accordingly.

Thrives under pressure in a dynamic, timeline-driven environment.

Self-motivated and capable of working independently with minimal management oversight.

Excellent root cause analysis, problem solving, and analytical skills.

Sampled is an Equal Opportunity / Affirmative Action Plan Employer (M/F/Disabled/Veteran)

Seniority level

• Seniority level

  Mid-Senior level

Employment type

• Employment type

  Full-time

Job function

• Job function

  Quality Assurance

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