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Fda Regulatory Jobs in Indiana (NOW HIRING)

Aequor

Regulatory Affairs Specialist

Warsaw, IN · On-site

Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills * Strong writing, communication, and interpersonal skills * Strong attention to ...

New

Aequor

... FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills Strong writing, communication, and interpersonal skills Strong attention to detail ...

New

Actalent

Regulatory Affairs Specialist

Warsaw, IN

$50 - $55/hr

Apply FDA regulations to business practices and provide regulatory input, advice, and guidance to design and development teams. * Collaborate closely with cross-functional teams, including ...

New

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $52/hr

Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills: * Strong writing, communication, and interpersonal skills * Strong attention ...

New

Net2Source (N2S)

Regulatory Affairs Specialist

Warsaw, IN · On-site

$48 - $52/hr

Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams Skills: * Strong writing, communication, and interpersonal skills * Strong attention ...

New

Synkriom

Be Seen First

Medical Device Regulatory Affairs Specialist

Warsaw, IN · On-site

$50 - $55/hr

Knowledge of FDA, EU, and other regulatory body regulations * Ability to identify risk in Regulatory strategies * Strong problem solving skills * Effective negotiating skills Basic computer skills ...

New

E Solutions

GMP Engineer

Indianapolis, IN · On-site

Regulatory & Quality Assurance * Maintain knowledge of industry regulations including FDA, GMP, and GAMP guidelines. * Develop and maintain validation procedures aligned with regulatory requirements.

E Solutions

GMP Engineer

Indianapolis, IN · On-site

Regulatory & Quality Assurance * Maintain knowledge of industry regulations including FDA, GMP, and GAMP guidelines. * Develop and maintain validation procedures aligned with regulatory requirements.

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How much do fda regulatory jobs pay per hour?

As of Aug 28, 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 2% As Needed, 84% Full Time, 11% Part Time, and 3% Contract. Highlights an 90% Physical, 3% Hybrid, and 7% Remote job distribution, with an average salary of $78,320 per year, or $37.7 per hour.

Regulatory Affairs Specialist

Warsaw, IN • On-site

Aequor
See more jobs at Aequorexternal

Other

Posted 2 days ago

New

Job description

Regulatory Affairs Specialist

1 Year Contract

Warsaw, IN (100% Onsite)


Duties

Responsible for assisting the team with regulatory filings as necessary to market our client's products. This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.


  • Assist with assembly, distribution, storage and tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process. May author and publish electronic submissions.
  • Respond to requests from foreign government and/or distributors as needed
  • Assist with the research, analysis and communication of information pertaining to the appropriate regulatory pathway for new or modified products
  • Provides regulatory direction to development project teams as a core team member; develops regulatory strategy for new products
  • Evaluate risk of proposed regulatory strategies; may offer solutions
  • Reviews proposed labeling for compliance with applicable global regulations
  • Writes and manages the development of package inserts
  • Reviews and evaluations promotion and advertising material for compliance with applicable regulations
  • Reviews proposed product changes for impact on regulatory status of the product
  • Communicates with regulatory and governmental agencies with supervision
  • Applies FDA regulations to business practices and provides regulatory input, advice and guidance to design teams


Skills

  • Strong writing, communication, and interpersonal skills
  • Strong attention to detail; ability to multi-task and balance competing priorities
  • Knowledge of overall business environment, the orthopaedic industry, and the marketplace
  • Ability to learn and stay abreast of regulations pertinent to medical devices, biologics, drugs and combination products as needed, based on functional area
  • Ability to building relationships between Regulatory Affairs and other areas of the organization; ability to communicate effectively at all levels
  • Knowledge of FDA, EU, and other regulatory body regulations
  • Ability to identify risk in Regulatory strategies
  • Strong problem solving skills
  • Effective negotiating skills
  • Basic computer skills, including Microsoft Office Suite


Education

  • Bachelor’s degree (or non-US equivalent) required; concentration in life sciences, technical/engineering or related field, preferred
  • A minimum of one year of experience in orthopaedic or medical device industry preferred
  • A minimum of 3 years of experience in Regulatory Affairs, Engineering, Quality, or related field required
  • Regulatory Affairs Certification (US or EU) preferred
  • A combination of education and experience may be considered


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