Regulatory Affairs Analyst Jobs in Indiana
Regulatory affairs analyst jobs in Indiana are concentrated in Indianapolis, the Midwest's most active hub for life sciences and pharmaceutical compliance, with additional demand in Columbus and South Bend. Eli Lilly, Zimmer Biomet, and Cook Medical are among the established Indiana employers that consistently hire regulatory affairs analysts across device submissions, pharmaceutical compliance, and FDA regulatory strategy. Openings range from entry-level associates supporting submission pipelines to senior analysts owning 510(k) and PMA filings independently. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 11+ Regulatory Affairs Analyst 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 Analyst Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Analyst Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs Analyst 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 analyst jobs across Indiana.
- Bachelor's degree in life sciences, pharmacy, engineering, or a closely related field
- Working knowledge of FDA regulations including 21 CFR Parts 820 and 211
- Experience preparing or reviewing regulatory submissions such as 510(k), PMA, or NDA filings
- Familiarity with quality management systems and document control processes
- Strong technical writing skills for regulatory documents and SOPs
- RAC certification from the Regulatory Affairs Professionals Society preferred by many Indiana employers
Regulatory Affairs Analyst Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs analyst in Indiana?
A bachelor's degree in a life sciences, engineering, or pharmacy field is the standard entry point for regulatory affairs analyst roles in Indiana. Indiana does not issue a state-specific license for this role, so employers focus on academic background, knowledge of FDA regulations, and hands-on experience with submissions or quality systems. Earning the Regulatory Affairs Professionals Society RAC credential strengthens candidacy considerably with the large medical device and pharmaceutical employers concentrated in Indianapolis.
Which companies hire regulatory affairs analysts in Indiana?
Employers hiring regulatory affairs analysts in Indiana right now include Roche, Eli Lilly, and Elanco, based on current listings on Migrate Mate as of September 2026. Indiana's concentration of medical device manufacturers and pharmaceutical companies, anchored by the Indianapolis life sciences corridor, produces some of the most consistent regulatory hiring volume in the Midwest.
Which Indiana cities have the most regulatory affairs analyst jobs?
Indianapolis, Warsaw, and Mishawaka account for the most regulatory affairs analyst openings in Indiana. Indianapolis dominates due to the dense cluster of pharmaceutical and medical device headquarters in the metro, while smaller markets like Columbus and South Bend appear because of major device manufacturers and healthcare system compliance functions based there.
Are there remote regulatory affairs analyst jobs in Indiana?
Yes, and more than most technical fields. Regulatory affairs work is largely document-driven and submission-based, which makes it well-suited to remote arrangements. About 0% of regulatory affairs analyst openings tied to Indiana are remote or hybrid as of September 2026, reflecting how broadly employers have accepted distributed work for this function. Submission writing, literature review, and dossier preparation are the tasks most commonly performed fully remote.
How can I get hired as a regulatory affairs analyst in Indiana with little or no experience?
The most realistic entry path is a quality assurance or regulatory affairs coordinator role at one of Indiana's medical device or pharmaceutical manufacturers, which routinely hire new graduates into document control and compliance support functions before moving them into analyst tracks. Eli Lilly and Zimmer Biomet both run structured early-career programs that feed into regulatory pipelines. A RAC-Associate credential or completion of a graduate certificate in regulatory affairs from Purdue or Indiana University gives candidates a concrete edge, and lateral moves from quality engineer or clinical trial coordinator roles are common in Indiana's device-heavy market.
Where can I find and apply to regulatory affairs analyst jobs in Indiana?
You can find and apply to regulatory affairs analyst jobs in Indiana on Migrate Mate, which lists current Indiana openings. Search the listings, identify the roles that match your background and target location, and apply directly to whichever ones fit your experience.
See All 11 Regulatory Affairs Analyst Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
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