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Fda Consulting Jobs in Indiana (NOW HIRING)

Versiti, Inc.

Technical Specialist

Indianapolis, IN · On-site

Serves as a technical resource and/or provides clinical consultation to laboratory staff, other ... AABB, FDA and CLIA regulations as applicable to the lab. With lab leadership, promotes and ...

CAI

Operational Readiness Project Manager

Indianapolis, IN · On-site

$140K - $175K/yr

We provide program and project management, commissioning, qualification, validation, start-up, and other consulting services associated with operational readiness and operational excellence to FDA ...

Versit

Technical Specialist

Indianapolis, IN · On-site

$110 - $150/hr

Serves as a technical resource and/or provides clinical consultation to laboratory staff, other ... AABB, FDA and CLIA regulations as applicable to the lab. With lab leadership, promotes and ...

Versiti, Inc.

Technical Specialist

Indianapolis, IN · On-site

Serves as a technical resource and/or provides clinical consultation to laboratory staff, other ... AABB, FDA and CLIA regulations as applicable to the lab. With lab leadership, promotes and ...

Versiti, Inc.

Technical Specialist

Indianapolis, IN · On-site

Serves as a technical resource and/or provides clinical consultation to laboratory staff, other ... AABB, FDA and CLIA regulations as applicable to the lab. With lab leadership, promotes and ...

Compass Group

CAPITAL PROJECT MANAGER

Mount Vernon, IN · On-site

$100K - $150K/yr

Coordinate engineering and design activities with internal engineering teams, consultants ... Ensure capital projects are executed in compliance with applicable FDA, cGMP, OSHA, environmental ...

Compass Group

CAPITAL PROJECT MANAGER

Mount Vernon, IN · On-site

$100K - $150K/yr

Coordinate engineering and design activities with internal engineering teams, consultants ... Ensure capital projects are executed in compliance with applicable FDA, cGMP, OSHA, environmental ...

AMARIS GROUP SA

Packaging Engineer I

Warsaw, IN · On-site

$55 - $75/hr

Knowledge of ISO 11607, ISO 13485, and/or FDA requirements. * Exposure to packaging validation ... Amaris Consulting isan independent technologyconsulting firm providing guidance and solutions to ...

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Fda Consulting information

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How much do fda consulting jobs pay per hour?

As of Sep 6, 2026, the average hourly pay for fda consulting in Indiana is $49.97, according to ZipRecruiter salary data. Most workers in this role earn between $20.82 and $66.35 per hour, depending on experience, location, and employer.

What is an FDA consulting?

An FDA Consulting job involves providing expert guidance to businesses seeking regulatory approval for their products from the U.S. Food and Drug Administration (FDA). Consultants help companies navigate complex FDA regulations, ensure compliance, and prepare necessary documentation for submissions. They may work with pharmaceuticals, medical devices, food, and biotech industries. Their role includes strategy development, risk assessment, and communication with the FDA to facilitate approvals and avoid compliance issues.

What does an FDA consultant do?

As an FDA Consultant, your day might involve reviewing regulatory documentation, preparing submissions for FDA approval, and advising clients on compliance strategies. You’ll often attend meetings with cross-functional teams including R&D, quality assurance, and legal experts to ensure alignment on regulatory requirements. Consultants also stay updated on changes in FDA guidelines, draft correspondence to regulatory agencies, and address client questions or concerns. This dynamic role requires adaptability and strong collaboration skills to manage multiple projects and effectively support clients through all stages of the regulatory process.

What skills and qualifications are needed for FDA consulting?

To thrive in FDA Consulting, you need expertise in regulatory affairs, a deep understanding of FDA guidelines, and often a degree in life sciences or a related field. Familiarity with regulatory submission systems such as eCTD, knowledge of GxP standards, and certifications like RAC (Regulatory Affairs Certification) are valuable. Strong communication, analytical thinking, and project management skills set outstanding consultants apart. These competencies are essential to effectively guide clients through complex regulatory landscapes and ensure successful product approvals.

What are the most commonly searched types of Fda Consulting jobs in Indiana?

The most popular types of Fda Consulting jobs in Indiana are:

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

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

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

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

Fda Consulting jobs near you
Infographic showing various Fda Consulting job openings in Indiana as of August 2026, with employment types broken down into 70% Full Time, 16% Part Time, and 14% Contract. Highlights an 100% In-person job distribution, with an average salary of $103,936 per year, or $50 per hour.

Technical Specialist

Versiti, Inc.

Indianapolis, IN • On-site

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 10 days ago

Versiti rating

5.7

Company rating: 5.7 out of 10

Based on 46 frontline employees who took The Breakroom Quiz

794th of 898 rated healthcare providers

Job description

Overview
Versiti is a fusion of donors, scientific curiosity, and precision medicine that recognize the gifts of blood and life are precious. We are home to the world-renowned Blood Research Institute, we enable life saving gifts from our donors, and provide the science behind the medicine through our diagnostic laboratories. Versiti brings together outstanding minds with unparalleled experience in transfusion medicine, transplantation, stem cells and cellular therapies, oncology and genomics, diagnostic lab services, and medical and scientific expertise. This combination of skill and knowledge results in improved patient outcomes, higher quality services and reduced cost of care for hospitals, blood centers, hospital systems, research and educational institutions, and other health care providers. At Versiti, we are passionate about improving the lives of patients and helping our healthcare partners thrive.
Position Summary
Under the direction of DL Leadership, provides guidance on technical issues to staff, leads quality and project initiatives, assists with technical & equipment troubleshooting, manages the development and implementation of new tests and assists with analysis and interpretation of complex test results in support of DL Hematology (Hemostasis Reference Lab, Molecular Oncology Genetics Lab, and Platelet & Neutrophil Immunology Lab), DL Histocompatibility or DL Immunohematology labs. This position has developed and demonstrated a level of quality and technical competence that allows for completing work in a highly independent and efficient manner and handling of complex technical issues. Provides support to clinical and research customers, including a high level of customer service and consultation on complex cases and problems. Trains and assesses competence of staff members and educational guests. In conjunction with the entire Lab Team, performs interpretation of complex patient test results, including consultations with clients, as required.
Total Rewards Package
Compensation
The target salary is based on internal averages. Versiti sets salary ranges aligned to local markets in which the job is performed. Compensation decisions take into account internal salary averages and differentiation based on education, experience, skills, and performance. Specific salary and benefits information is shared at the time of the phone screening based on your location and qualifications.
Benefits
Versiti provides a comprehensive benefits package based on your job classification. Full-time regular employes are eligible for Medical, Dental, and Vision Plans, Paid Time Off (PTO) and Holidays, Short- and Long-term disability, life insurance, 7% match dollar for dollar 401(k), voluntary programs, discount programs, others.
Responsibilities
  • Assists with test selection, analysis, review, and interpretation for clinical and VCT patients. Leads assay, sample, result, and equipment troubleshooting. Performs testing on clinical and/or clinical/contract research samples as needed. Performs management final review of result review and release Histocompatibility and Immunohematology: Part of the management on-call rotation for results review and release.
  • Serves as a technical resource and/or provides clinical consultation to laboratory staff, other labs/departments, and/or external customers as needed. Trains and assesses competence of clinical diagnostic lab staff. Provides orientation to testing personnel. Assists in the creation of training materials for staff and students, as needed.
  • Per regulatory requirements, monitors test analysis and specimen examinations to ensure that acceptable levels of analytic performance are maintained. Assures that all remedial actions are taken when test systems deviate from the laboratory's established performance specifications. Ensures that patient test results are not reported until all corrective actions have been taken and the test system is properly functioning.
  • Serves as an internal resource regarding quality testing and reporting regarding the requirements of CAP (College of American Pathology), AABB, FDA and CLIA regulations as applicable to the lab. With lab leadership, promotes and maintains compliance of lab operations with all applicable policies, standards, and regulations. Assists with operating within the Quality Management System (QMS), including all systems that support the QMS. Provides support during internal and external audits/assessments as needed.
  • Responsible for management of specific projects, such as test enhancements, continuous improvement projects, or new equipment implementations; evaluates needs, plans, facilitates, delegates, and/or performs tasks ensuring project completion within designated timeframes.
  • Remains current and knowledgeable on trends in lab practices, relevant regulations, and business climate. Stays abreast of latest technology and trends in diagnostic testing and looks for innovative product and service ideas to serve more patients in new or better ways.
  • Accountable for equipment, technology, reagent, and software improvements and/or implementations working with internal and external resources to serve more patients in new or better ways.
  • Per regulatory requirements, accessible to testing personnel at all time testing is performed providing on-site, telephone, or electronic consultation, providing day-to-day supervision of High complexity test performance.
  • Evaluates, qualifies, and recommends suppliers for equipment, software, and/or reagent purchasing. Collaborates with other laboratories for supplier leverage. Performs cost analysis of current tests and procedures. Partners with the leadership team in areas of technology, compliance, customer service, and process control.
  • Establishes educational partnerships with local educational institutions to increase Versiti visibility and to enhance recruitment potential. Attends and presents at relevant local, national, and international meetings. Serves as technical and clinical education resource and liaison for potential, new, and existing customers. May provide scientific support to Business Development team.
  • Performs other duties as required or assigned which are reasonably within the scope of the duties in this job classification
  • Understands and performs in accordance with all applicable regulatory and compliance requirements
  • Complies with all standard operating policies and procedures

Qualifications
Education
  • Bachelor's Degree in Medical Laboratory Science or one of the chemical, physical, or biological sciences from an accredited college or university required
  • Master's Degree from an accredited institution with a major in one of the chemical, physical or biological sciences in lieu of required degree

Experience
  • 4-6 years Four years (post degree) related clinical laboratory experience to include at least two years under a director at the doctoral level required
  • Histocompatibility: Three years of laboratory training or experience in human immunogenetics, human histocompatibility and/or human transplantation immunology under the supervision of a director and/or technical supervisor of an ASHI-accredited or an equivalent ARB approved laboratory required
  • 4-6 years Immunohematology: 4-6 years working in an Immunohematology Reference Laboratory or Transfusion Service required

Knowledge, Skills and Abilities
  • Knowledge of good laboratory practices and quality systems required
  • Working knowledge of and experience with regulations related to CLIA (Clinical Laboratory Improvement Act), serologic and molecular testing, and quality assurance concepts/practices required
  • Experience serving as a subject matter expert (SME) to laboratory staff, other labs/departments, regulatory agencies, and/or external customers as needed required
  • Well developed skills in the planning, organizing and management of cross-functional teams with the ability to influence and motivate others in implementing process changes required
  • Strong detail orientation and analytical ability required
  • Effective oral and written communication skills required
  • Computer skills including word processing, electronic spreadsheets, and other database software programs required

Licenses and Certifications
  • ABHI - American Board of Histocompatibility and Immunogenetics Histocompatibility: Certified Histocompatibility Specialist (CHS) or Technologist (CHT) within 1 Year required
  • Immunohematology: MLS (ASCP) and SBB certifications or equivalents; within 1 Year required

Tools and Technology
  • Personal computer, Microsoft Suite, laboratory information system, specialized software programs, and various lab instrumentation required

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