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Regulatory Writing Jobs in Indiana (NOW HIRING)

Zimmer, Inc.

Regulatory Affairs Specialist

Warsaw, IN · On-site

Write and manage the development of package inserts. * Review and evaluate promotion and advertising material for compliance with applicable regulations. * Review proposed product changes for impact ...

Jj

Manager, Regulatory Intelligence

Warsaw, IN · On-site

Regulatory Affairs Job Category: Professional All Job Posting Locations: Palm Beach Gardens ... Excellent written and verbal communication skills, with the ability to translate complex ...

Ambu

Specialist, Regulatory Affairs

Noblesville, IN · On-site

Regulatory Affairs Department: RA, Noblesville Employment Type: Full-time Req ID: 9930 Ambu ... Must be able to read, write and understand English. About Ambu Ambu has been bringing the solutions ...

Tmhcc

Compliance Analyst, Regulatory

Carmel, IN · Hybrid

The Compliance Analyst, Regulatory is responsible for ensuring compliance with insurance and ... Solid written and verbal communication skills with an emphasis on confidentiality, tact, and ...

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Regulatory Writing information

See Indiana salary details

$14

$32

$138

How much do regulatory writing jobs pay per hour?

As of Jun 16, 2026, the average hourly pay for regulatory writing in Indiana is $32.92, according to ZipRecruiter salary data. Most workers in this role earn between $21.25 and $24.95 per hour, depending on experience, location, and employer.

What are some common challenges faced by Regulatory Writers in the industry?

Regulatory Writers often face tight deadlines and the need to manage complex, highly detailed documents that must comply with evolving regulatory requirements. They regularly coordinate input from diverse teams such as clinical, safety, and regulatory affairs, which can pose communication and alignment challenges. Staying current with changing international regulations and ensuring absolute accuracy in submissions are other common demands. However, these challenges also make the work engaging and offer opportunities to continuously learn and develop expertise in both scientific communication and regulatory affairs.

What does a regulatory writer do?

A regulatory writer creates and prepares documentation required for regulatory submissions, such as clinical trial protocols, reports, and product labeling, ensuring compliance with industry standards and regulations. They often work closely with scientists, regulatory agencies, and quality teams, using tools like document management systems and adhering to guidelines like FDA or EMA requirements.

How much do regulatory writers make?

Regulatory writers typically earn between $70,000 and $120,000 annually, depending on experience, industry, and location. Senior roles or those with specialized knowledge in areas like pharmaceuticals or biotechnology can earn higher salaries, often exceeding $130,000. Strong writing skills, knowledge of regulatory guidelines, and familiarity with document management tools are important for this role.

What are the key skills and qualifications needed to thrive in the Regulatory Writing position, and why are they important?

To thrive in Regulatory Writing, you need expertise in scientific or medical writing, an understanding of regulatory guidelines (such as FDA, EMA, or ICH), and typically a background in life sciences or related fields. Competence with document management systems, referencing tools like EndNote, and familiarity with submission platforms are often required. Strong organizational skills, attention to detail, and the ability to collaborate across multidisciplinary teams are key soft skills. These skills ensure the creation of accurate, compliant, and clear regulatory documents critical for drug and device approval processes.

Are medical writers going to be replaced by AI?

Regulatory writers, including medical writers, are unlikely to be fully replaced by AI because their work requires critical thinking, understanding complex scientific data, and ensuring compliance with regulatory standards. AI tools can assist with drafting and data analysis, but human expertise remains essential for accuracy, interpretation, and ethical considerations in regulatory documentation.

What is the highest paying writing job?

In the field of regulatory writing, senior roles such as Regulatory Affairs Director or Vice President typically offer the highest salaries, often exceeding six figures annually. These positions require extensive industry experience, strong knowledge of regulations, and leadership skills, and they may involve overseeing multiple projects or teams within pharmaceutical, biotech, or medical device companies.

What is a Regulatory Writing job?

A Regulatory Writing job involves creating and reviewing documents required for regulatory submissions in industries like pharmaceuticals, biotechnology, and medical devices. Regulatory writers ensure that documents comply with guidelines from regulatory agencies such as the FDA or EMA. Their work includes clinical study reports, investigator brochures, and regulatory submission dossiers. Strong writing skills, scientific knowledge, and attention to detail are essential for this role.

What are the most commonly searched types of Regulatory Writing jobs in Indiana? The most popular types of Regulatory Writing jobs in Indiana are:
What are popular job titles related to Regulatory Writing jobs in Indiana? For Regulatory Writing jobs in Indiana, the most frequently searched job titles are:
What job categories do people searching Regulatory Writing jobs in Indiana look for? The top searched job categories for Regulatory Writing jobs in Indiana are:
What cities in Indiana are hiring for Regulatory Writing jobs? Cities in Indiana with the most Regulatory Writing job openings:
Regulatory Writing jobs near you
Infographic showing various Regulatory Writing job openings in Indiana as of June 2026, with employment types broken down into 82% Full Time, 14% Part Time, and 4% Contract. Highlights an 90% Physical, 4% Hybrid, and 6% Remote job distribution, with an average salary of $68,475 per year, or $32.9 per hour.

Regulatory Affairs Specialist

Zimmer, Inc.

Warsaw, IN • On-site

Other

Posted 4 days ago

Job description

Valued Team member: We are glad you are exploring new opportunities within Zimmer Biomet!


What You Can Expect

As a Regulatory Affairs Specialist, you are responsible for assisting the team with regulatory filings as necessary to market Zimmer Biomet products.

This position requires an intermediate understanding of medical devices and their use as well as an understanding of the regulatory submission process.

How You'll Create Impact
  • 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.
  • Provide 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.
  • Review proposed labeling for compliance with applicable global regulations.
  • Write and manage the development of package inserts.
  • Review and evaluate promotion and advertising material for compliance with applicable regulations.
  • Review proposed product changes for impact on regulatory status of the product.
  • Communicate with regulatory and governmental agencies with supervision.
  • Apply FDA regulations to business practices and provides regulatory input, advice and guidance to design teams.
What Makes You Stand Out

You have strong writing, communication, and interpersonal skills, with excellent attention to detail and the ability to manage multiple priorities.

You understand the business environment, the orthopaedic industry, and market dynamics, and you stay current with regulations affecting medical devices, biologics, drugs, and combination products.

In addition, you bring knowledge of FDA, EU, and other applicable regulatory requirements, the ability to identify risk within regulatory strategies, strong problem-solving and negotiation skills,

You build effective cross-functional relationships, communicate confidently at all levels, and are proficient in Microsoft Office Suite and standard computer applications.

Your Background

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

Travel Expectations

Up to 15%.


EOE/M/F/Vet/Disability

Employment Type: OTHER

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