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Fda Regulatory Jobs in Indiana (NOW HIRING)

OSI Group

FSQA Manager

Morristown, IN

Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. Ensure that complete and accurate records are ...

OSI INDUSTRIES, LLC

FSQA Manager

Morristown, IN · On-site

Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...

OSI Group

FSQA Manager

Morristown, IN · On-site

Ensure compliance and effective implementation of company standards, GFSI requirements, and all applicable customer standards and USDA/FDA regulations. * Ensure that complete and accurate records are ...

MediSphere Medical Research Center, LLC

Be Seen First

Clinical Research Assistant II

Evansville, IN · On-site

Follow Good Clinical Practice (GCP), FDA regulations, study protocols, and MediSphere Standard Operating Procedures. * Assist with sponsor monitoring visits, audits, and regulatory inspections.

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How much do fda regulatory jobs pay per hour?

As of Sep 3, 2026, the average hourly pay for fda regulatory in Indiana is $37.65, according to ZipRecruiter salary data. Most workers in this role earn between $30.19 and $44.62 per hour, depending on experience, location, and employer.

What is an FDA Regulatory?

An FDA Regulatory job involves ensuring that products such as pharmaceuticals, medical devices, and biologics comply with U.S. Food and Drug Administration (FDA) regulations. Professionals in this field prepare and submit regulatory documents, monitor compliance with changing laws, and help companies navigate the approval process. They work closely with internal teams and regulatory agencies to ensure safety, efficacy, and legal adherence.

What are the main responsibilities of an FDA Regulatory?

Professionals in FDA Regulatory roles are primarily responsible for preparing, reviewing, and submitting documents to the FDA to support the approval of pharmaceuticals, medical devices, or other regulated products. You will monitor regulatory changes, ensure company practices comply with relevant laws, and serve as a liaison between your organization and the FDA. Daily tasks often involve cross-functional collaboration with research, quality assurance, and product development teams. This role is both fast-paced and detail-oriented, requiring you to manage multiple projects and adapt to evolving regulatory landscapes.

What are the key skills and qualifications needed to thrive in an FDA Regulatory position?

To thrive in an FDA Regulatory role, you must have a thorough understanding of FDA regulations, submission requirements, and scientific or technical documentation, usually supported by a degree in life sciences or a related field. Proficiency with regulatory submission software (such as eCTD), knowledge of guidance documents, and sometimes RAC certification are highly valued. Strong organizational abilities, problem-solving skills, and clear communication are essential soft skills for coordinating between internal teams and external agencies. These qualifications are vital to ensure compliance, successful product approvals, and effective interaction with regulatory authorities.

How can I get into FDA regulatory?

To enter FDA regulatory roles, candidates typically need a background in life sciences, healthcare, or engineering, along with knowledge of FDA regulations and compliance processes. Relevant experience can be gained through internships, certifications such as RAC (Regulatory Affairs Certification), or working in quality assurance or compliance departments. Strong analytical skills, attention to detail, and understanding of medical device or pharmaceutical development are also important.

What are popular job titles related to Fda Regulatory jobs in Indiana?

For Fda Regulatory jobs in Indiana, the most frequently searched job titles are:

What job categories do people searching Fda Regulatory jobs in Indiana look for?

The top searched job categories for Fda Regulatory jobs in Indiana are:

Fda Regulatory jobs near you
Infographic showing various Fda Regulatory job openings in Indiana as of August 2026, with employment types broken down into 1% As Needed, 85% Full Time, 11% Part Time, and 3% Contract. Highlights an 89% Physical, 4% Hybrid, and 7% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Quality & Regulatory Specialist

Med Mizer Inc

Batesville, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 16 days ago

Job description

Quality & Regulatory Specialist - FDA QMSR & ISO 13485 Medical Device Manufacturing
Company Overview
Med-Mizer is a leading manufacturer of hospital beds, specialty seating, and safe patient-handling solutions. Our mission is to provide high-quality, innovative products that enhance patient care and safety. We are seeking a hands-on Quality & Regulatory Specialist who can support and continuously improve our FDA QMSR & ISO 13485 Quality Management System to support our manufacturing operations. The ideal candidate will have a strong background in manufacturing quality systems and safety regulations. This position will work closely with the QA/RA Manager and operational teams to maintain a safe, compliant, and efficient work environment while supporting quality objectives throughout the organization.
Med-Mizer, Inc. is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or veteran status.
Position: Quality & Regulatory Specialist
Schedule: Monday - Friday 6:00am - 3:00pm
Key Responsibilities
Quality Management System (QMS)
  • Manage and maintain the FDA QMSR / ISO 13485 Quality Management System.
  • Ensure compliance with all applicable regulatory and customer requirements.
  • Oversee document control and record retention processes.
  • Coordinate Management Review activities and present quality system performance metrics.
  • Ensure quality objectives are established, monitored, and achieved.
  • Maintain inspection readiness and audit preparedness.

CAPA and Nonconformance Management
  • Lead the Corrective and Preventive Action (CAPA) program.
  • Ensure timely investigation and closure of quality issues.
  • Facilitate root cause investigations.
  • Monitor effectiveness of corrective actions.
  • Manage nonconforming product processes and disposition activities.

Risk Management
  • Ensure risk management activities comply with ISO 14971 requirements.
  • Participate in risk assessments associated with products, processes, equipment, and suppliers.
  • Support implementation of risk controls and verification of effectiveness.
  • Ensure risk management files remain current and complete.

Validation and Quality Engineering Support
  • Review and approve validation protocols and reports.
  • Support process improvement and process capability initiatives.
  • Ensure manufacturing changes are properly evaluated and validated.

Internal Audits and Regulatory Inspections
  • Manage the internal audit program.
  • Coordinate external audits, customer audits, certification audits, and regulatory inspections.
  • Track audit findings through closure.

Supplier Quality Management
  • Ensure supplier qualifications and monitoring programs meet ISO 13485 requirements.
  • Manage supplier audits and supplier performance reviews.
  • Oversee supplier corrective action requests (SCARs).
  • Support supplier risk assessments and change management.

Customer Quality and Complaint Handling
  • Manage customer complaint investigations.
  • Ensure complaint-handling processes meet applicable regulatory requirements.
  • Analyze customer quality trends and implement improvement actions.
  • Serve as primary escalation point for customer quality issues.

Training and Quality Culture
  • Ensure employee training programs meet regulatory and quality requirements.
  • Verify personnel competency for quality-critical tasks.
  • Promote quality awareness throughout the organization.
  • Support continuous improvement initiatives across all departments.

Success Measures
  • Successful maintenance of ISO 13485 implementation
  • Timely closure and effectiveness of CAPAs
  • Reduction in customer complaints and internal quality issues
  • Successful completion of internal, customer, and certification audits
  • Supplier quality performance improvements
  • On-time completion of Management Reviews and Quality Objectives

Qualifications
Preferred Background
  • Bachelor's degree in Engineering, Quality, Manufacturing, Life Sciences, or related field.
  • 3+ years of progressive quality experience in a regulated manufacturing environment.
  • 3+ years working with ISO 13485 Quality Management Systems.
  • Experience leading internal, customer, and certification audits.
  • Strong knowledge of CAPA, nonconformance management, change control, complaint handling, and supplier quality.
  • Experience in FDA-regulated medical device manufacturing is highly preferred.

Technical Expertise: demonstrated experience with:
  • FDA QMSR / ISO 13485
  • CAPA systems
  • Internal auditing
  • Risk management (ISO 14971 preferred)
  • Supplier qualification and supplier corrective actions
  • Validation activities (IQ/OQ/PQ)
  • Complaint investigations
  • Document control and change management

Physical Requirements
  • Primarily office-based with time spent in manufacturing environments.
  • Ability to walk production floors as needed to support quality and regulatory systems.
  • Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Compensation & Benefits
  • Competitive salary (exempt position)
  • Annual bonus program
  • Three weeks of paid vacation
  • Ten paid holidays per year
  • Health, Dental, Vision, and Life Insurance (immediate eligibility)
  • Health Savings Account (HSA) option
  • 401(k) retirement plan options
  • Family owned and growing company environment

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