Regulatory Affairs Director Jobs in Indiana
Regulatory affairs director jobs in Indiana concentrate in life sciences, medical devices, and pharmaceutical manufacturing, sectors where the state has built a nationally recognized footprint anchored by companies like Eli Lilly, Cook Medical, and Zimmer Biomet. The strongest hiring metros are Indianapolis, Warsaw, and Fort Wayne, reflecting where Indiana's device and biopharma operations are densest. The most in-demand specialties are FDA submissions and compliance, quality systems management, and combination product regulation. Scan the live roles below and apply to whichever ones fit.
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Showing 5 of 11+ Regulatory Affairs Director 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 Director Jobs in Indiana
Find roles in Indiana that match your experience and apply in just a few clicks.
Find JobsRegulatory Affairs Director Jobs by City in Indiana
Where Indiana roles are concentrated, by current openings.
Regulatory Affairs Director 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 director jobs across Indiana.
- Bachelor's degree in life sciences, engineering, or a related technical discipline required
- Minimum seven to ten years of regulatory affairs experience in medical devices or pharmaceuticals
- Demonstrated experience leading FDA submissions including 510(k), PMA, or NDA filings
- Proficiency with RAC or RAPS certification strongly preferred by Indiana employers
- Proven ability to manage cross-functional teams and direct regulatory strategy at a senior level
- Familiarity with ISO 13485, 21 CFR Part 820, and international regulatory frameworks
Regulatory Affairs Director Jobs in Indiana: Frequently Asked Questions
How do you become a regulatory affairs director in Indiana?
The path to a regulatory affairs director role in Indiana typically begins with a bachelor's degree in a life sciences or engineering field, followed by progressive experience in regulatory affairs within medical devices or pharmaceuticals. Indiana does not require a state-issued license specific to this role, but the Regulatory Affairs Certification (RAC) awarded by RAPS is the industry standard credential that Indiana employers, especially those in the Warsaw device corridor and Indianapolis biopharma hub, consistently look for at the director level.
How much do regulatory affairs directors make in Indiana?
Regulatory affairs directors 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 directors in Indiana?
Employers hiring regulatory affairs directors 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 in the Warsaw area and global pharmaceutical operations centered in Indianapolis means director-level regulatory roles appear consistently with large, established employers rather than being limited to startup activity.
Which Indiana cities have the most regulatory affairs director jobs?
The cities with the most regulatory affairs director openings in Indiana are Indianapolis, Warsaw, and Mishawaka. Indianapolis leads because it is home to Eli Lilly's global headquarters and a broad ecosystem of biopharma and diagnostics companies, while Warsaw draws significant hiring from the orthopedic and surgical device manufacturers that have made that region the recognized center of the global orthopedics industry.
Are there remote regulatory affairs director jobs in Indiana?
Yes, and more than many senior roles allow, given that much of a regulatory affairs director's work involves document strategy, submissions review, and agency correspondence that does not require physical presence. About 0% of regulatory affairs director openings tied to Indiana are remote or hybrid as of September 2026, though roles requiring direct oversight of manufacturing quality systems or on-site FDA audit response tend to require at least a hybrid schedule. Submissions-focused and global regulatory strategy roles are the most consistently remote-eligible.
How can I get hired as a regulatory affairs director in Indiana with little or no experience?
The most realistic entry path is a lateral move into a regulatory affairs specialist or coordinator role from an adjacent function such as quality assurance, clinical affairs, or scientific writing, which is how most Indiana director-level professionals built their foundation. Large Indiana device employers in Warsaw and Indianapolis regularly recruit quality and compliance professionals into entry regulatory roles where they gain submission and audit experience. Pursuing the RAC credential early and contributing to a 510(k) or NDA submission in any capacity, even in a support role, accelerates the progression toward director eligibility.
Where can I find and apply to regulatory affairs director jobs in Indiana?
You can find and apply to regulatory affairs director jobs in Indiana on Migrate Mate, which lists current Indiana openings updated regularly. Search the available roles, identify the ones that match your background and target location, and apply directly to the ones that fit.
See All 11 Regulatory Affairs Director Jobs in Indiana
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