Regulatory Affairs Jobs in Indiana
Regulatory affairs jobs in Indiana are steadily active, with the strongest demand concentrated in pharmaceutical manufacturing, medical device development, and life sciences, drawing candidates from entry-level compliance associates through senior regulatory managers. Indianapolis anchors the market, while Bloomington and Fort Wayne add meaningful volume through established life sciences and manufacturing employers such as Eli Lilly, Cook Medical, and Zimmer Biomet. The most sought-after specialties are FDA submissions, quality systems compliance, and drug or device labeling. See the openings below and apply to the ones that match your experience.
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Showing 5 of 11+ Regulatory Affairs jobs
Sr. Regulatory Affairs Specialist
Position Summary
The Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and standards. The position requires good knowledge of industry regulations and effective communication skills to guide and inform various stakeholders. The Regulatory Engineer will ensure that the regulatory-related requirements from our customers are communicated clearly and concisely to all employees to ensure that the company meets domestic and international customer and governmental regulatory requirements. The Sr. Regulatory Affairs Specialist assists in teaching regulatory requirements and best practices to team members. Conduct 1st and second party audits to assess adherence to the QMS and domestic as well as international regulations.
This accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.
Principle Responsibilities
- Field complaint investigations and reporting
- Perform regulatory reviews of Tecomet standard product and customer co-development design files to approve for release
- Collaborate with other departments to address compliance issues
- Provide training and support to staff on compliance matters
- Act as a liaison between the company and regulatory bodies
- Investigate and resolve compliance violations
- Stay updated with changes in regulatory landscape and industry standards
- Advise senior management on compliance risks and mitigation strategies
- Maintain current knowledge of relevant regulations
- Create Declarations of Conformities for release
- Regulatory reviews of memos to file
- ODCR reviews
- Participate in ISO audits and Technical File Reviews
- Annual review of all Tecomet products (PMS)
- Manage domestic/international medical device distribution submissions
- Participate in design reviews
- Maintain FDA MDL listings/submissions for Tecomet and Customer products
- Create and submit Certificates to Foreign Government for Tecomet products
- Participate in ISO audits and Technical File Reviews
- Conduct First and Second Party Audits to Regulatory Standards
- Effectively document clear and concise audit reports and findings
- Evaluate corrective action in response to observations made throughout audit process
- Annual review of all Tecomet products (PMS)
- Additional functions and requirements may be assigned by manager as deemed appropriate
Qualification Requirements
Credentials/Experience:
- Working knowledge of government(s), international, and national regulations regarding medical devices (i.e. FDA, MDD, CMDCAS, PAL, ISO etc.)
- Minimum Four years of experience in a quality and regulatory related field or equivalent combination of education and experience.
Experience/Educational/Training Preferred:
- Bachelor of Science Degree Preferred.
Knowledge, Skills, and Abilities:
- Ability to read, analyze, and interpret technical journals, technical procedures, and/or government procedures
- Ability to respond to common inquiries or complaints from customers, or regulatory agencies
- Ability to define problems, collect data, establish facts, and interpret technical instructions to draw valid conclusions
- Ability to handle multiple projects simultaneously
- Effective organizational skills
- Computer skills – Proficient in MS Word, Excel, and PowerPoint
- Familiarity with risk management and mitigation
- Manufacturing-related knowledge of medical devices to effectively conduct strategic process adequacy risk assessments
- Team-oriented attitude
- Ability to work in a proactive and reactive environment
- Ability to deal with complex and difficult situations unsupervised
- Ability to maintain confidentiality of information
Other Requirements
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.
Travel Requirements
Up to 10%
Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.Sr. Regulatory Affairs Specialist
Position Summary
The Sr. Regulatory Affairs Specialist will be Responsible for regulatory affairs activities to assist in regulatory submission, annual reports, registrations and listings. Ensuring that the company adheres to all relevant laws, regulations, and standards. The position requires good knowledge of industry regulations and effective communication skills to guide and inform various stakeholders. The Regulatory Engineer will ensure that the regulatory-related requirements from our customers are communicated clearly and concisely to all employees to ensure that the company meets domestic and international customer and governmental regulatory requirements. The Sr. Regulatory Affairs Specialist assists in teaching regulatory requirements and best practices to team members. Conduct 1st and second party audits to assess adherence to the QMS and domestic as well as international regulations.
This accomplished by maintaining Tecomet principles of Safety, Quality, Customer Satisfaction and Innovations.
Principle Responsibilities
- Field complaint investigations and reporting
- Perform regulatory reviews of Tecomet standard product and customer co-development design files to approve for release
- Collaborate with other departments to address compliance issues
- Provide training and support to staff on compliance matters
- Act as a liaison between the company and regulatory bodies
- Investigate and resolve compliance violations
- Stay updated with changes in regulatory landscape and industry standards
- Advise senior management on compliance risks and mitigation strategies
- Maintain current knowledge of relevant regulations
- Create Declarations of Conformities for release
- Regulatory reviews of memos to file
- ODCR reviews
- Participate in ISO audits and Technical File Reviews
- Annual review of all Tecomet products (PMS)
- Manage domestic/international medical device distribution submissions
- Participate in design reviews
- Maintain FDA MDL listings/submissions for Tecomet and Customer products
- Create and submit Certificates to Foreign Government for Tecomet products
- Participate in ISO audits and Technical File Reviews
- Conduct First and Second Party Audits to Regulatory Standards
- Effectively document clear and concise audit reports and findings
- Evaluate corrective action in response to observations made throughout audit process
- Annual review of all Tecomet products (PMS)
- Additional functions and requirements may be assigned by manager as deemed appropriate
Qualification Requirements
Credentials/Experience:
- Working knowledge of government(s), international, and national regulations regarding medical devices (i.e. FDA, MDD, CMDCAS, PAL, ISO etc.)
- Minimum Four years of experience in a quality and regulatory related field or equivalent combination of education and experience.
Experience/Educational/Training Preferred:
- Bachelor of Science Degree Preferred.
Knowledge, Skills, and Abilities:
- Ability to read, analyze, and interpret technical journals, technical procedures, and/or government procedures
- Ability to respond to common inquiries or complaints from customers, or regulatory agencies
- Ability to define problems, collect data, establish facts, and interpret technical instructions to draw valid conclusions
- Ability to handle multiple projects simultaneously
- Effective organizational skills
- Computer skills – Proficient in MS Word, Excel, and PowerPoint
- Familiarity with risk management and mitigation
- Manufacturing-related knowledge of medical devices to effectively conduct strategic process adequacy risk assessments
- Team-oriented attitude
- Ability to work in a proactive and reactive environment
- Ability to deal with complex and difficult situations unsupervised
- Ability to maintain confidentiality of information
Other Requirements
Work Environment
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Physical Requirements
The employee could frequently be required to walk; use hand to finger, handle, or feel; reach with hands and arms and talk or hear. The employee could be required to sit; climb or balance and stoop, kneel, crouch, or crawl. The employee could occasionally lift and or move up to 50 pounds. Specific vision abilities required by the job could include close vision, distance vision, peripheral vision and ability to adjust focus.
Travel Requirements
Up to 10%
Pay Transparency In order to support the Fair Compensation Strategy by the US Govt., HR Dept., clients are required to adhere to "Pay Transparency Law"; in the impacted states; that have mandated the employers to list the salary ranges in Job advertisements or postings for job opportunities and Job promotions.See All 11 Regulatory Affairs Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs Job Market in Indiana
A snapshot from current Indiana openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Biotechnology & Pharmaceuticals
- Science & Research
What Indiana Employers Look For
The qualifications that appear most often in regulatory affairs jobs across Indiana.
- Bachelor's degree in life sciences, pharmacy, chemistry, or a related technical field
- Experience with FDA submissions including 510(k), PMA, NDA, or BLA filings
- Working knowledge of 21 CFR regulations governing drugs, biologics, or medical devices
- Familiarity with quality management systems and ISO 13485 or ICH guidelines
- Strong technical writing skills for regulatory documents, dossiers, and SOPs
- Proficiency with regulatory information management or document control software platforms
Regulatory Affairs Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs professional in Indiana?
Most regulatory affairs roles in Indiana require a bachelor's degree in a life sciences, pharmacy, or engineering field, and the state does not issue a separate regulatory affairs license. Employers in Indiana's pharmaceutical and medical device sectors, including those in Indianapolis and Bloomington, typically expect candidates to hold or pursue the Regulatory Affairs Certification offered by the Regulatory Affairs Professionals Society, which signals validated competency in FDA and international regulatory frameworks.
How much do regulatory affairses make in Indiana?
Regulatory affairses in Indiana earn a median of about $78,770 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $47,650 for the lowest 10% to over $134,820 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs professionals in Indiana?
Employers hiring regulatory affairs professionals in Indiana right now include Roche, Eli Lilly, and Elanco, based on current listings on Migrate Mate as of September 2026. Indiana's deep concentration of pharmaceutical headquarters and medical device manufacturers means openings appear across both large multinationals and specialized mid-size companies anchored in the Indianapolis and Bloomington corridors.
Which Indiana cities have the most regulatory affairs jobs?
The cities with the most regulatory affairs openings in Indiana are Indianapolis, Warsaw, and Mishawaka. Indianapolis dominates because it is home to Eli Lilly's global headquarters and a dense cluster of contract research organizations and device firms, while Bloomington and Warsaw generate steady demand through Cook Medical, Zimmer Biomet, and an ecosystem of orthopedic and surgical device manufacturers that have operated there for decades.
Are there remote regulatory affairs jobs in Indiana?
Yes, and more than most fields. Regulatory affairs work is primarily documentation-driven and does not require routine on-site lab or manufacturing presence, making it well-suited for remote and hybrid arrangements. About 0% of regulatory affairs openings tied to Indiana are remote or hybrid as of September 2026, reflecting a broad shift among pharmaceutical and device employers post-pandemic. Submissions writing, labeling review, and regulatory strategy roles are most commonly offered on flexible location terms.
How can I get hired as a regulatory affairs professional in Indiana with little or no experience?
The most realistic entry path is through a quality assurance or regulatory compliance associate role at one of Indiana's pharmaceutical or medical device manufacturers, where hands-on exposure to SOPs, document control, and FDA audit preparation builds transferable credentials. Eli Lilly, Cook Medical, and Roche Diagnostics all run structured rotational or early-career programs from their Indiana sites. Candidates who pair a life sciences degree with coursework in regulatory affairs or pursue the RAC credential through the Regulatory Affairs Professionals Society stand out in Indiana applicant pools, as do those with internship experience in a GMP-regulated environment.
Where can I find and apply to regulatory affairs jobs in Indiana?
You can find and apply to regulatory affairs jobs in Indiana on Migrate Mate, which lists current Indiana openings updated regularly. Search the listings for roles that match your background in pharmaceuticals, medical devices, or biologics, then apply directly to the ones that fit your experience level and preferred location.
See All 11 Regulatory Affairs Jobs in Indiana
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