Regulatory Affairs Jobs in Michigan
Regulatory affairs jobs in Michigan are concentrated in the state's robust automotive, pharmaceutical, and medical device sectors, with demand at every level from entry-level specialists through senior directors and vice presidents. Detroit, Grand Rapids, and Ann Arbor account for the largest share of openings, anchored by employers such as Ford Motor Company, Stryker, and Pfizer's Michigan operations. The most sought-after specialties are FDA submission management, automotive compliance, and medical device quality systems. Find a role that fits below and apply directly.
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Showing 5 of 11+ Regulatory Affairs jobs
COMPANY DESCRIPTION
At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!
POSITION SUMMARY
The Regulatory Affairs Specialist supports the preparation and maintenance of regulatory submissions, product registrations, and quality system documentation to ensure compliance with global medical device regulations. This includes documentation legalization for the support of international product registrations handled locally/physically and the coordination of document legalization with outside agencies and the ownership of the legalization process. This entry-level role provides administrative and technical assistance to the Regulatory Affairs Systems team.
POSITION QUALIFICATIONS
Knowledge, Skills, & Abilities:
- Basic knowledge of medical device regulations (21CFR), FDA regulations, EU MDD/MDR, other global laws and regulations and standards including ISO 14971, ISO 13485/MDSAP and related particular standards.
- Strong organizational skills and attention to detail.
- Effective written and verbal communication skills.
- Ability to manage multiple priorities and deadlines.
- Proficient computer skills in Microsoft Office.
- Experience with project deliverables and timelines for global regulatory submissions, preferred.
Level of Experience:
- 0–2 years of experience in regulatory affairs, specifically within the respiratory and anesthesia sector.
Level of Education:
- Bachelor’s degree preferably in Regulatory Affairs and/or an engineering or science related field or equivalent experience in the medical device and/or pharmaceutical industry.
Travel:
As the business needs. Local travel to complete physical document legalization required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assist in preparation of regulatory submissions and product registrations.
- Maintain regulatory files and databases.
- Support change control and quality system documentation.
- Provide administrative support during audits and inspections.
- Increase collaboration to address customer quality and delivery along with adherence to regulatory compliance.
- Formulate and provide support for regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying, and executing company regulatory strategies and policies that affect immediate AirLife Business Group operations supporting go-to-market launches and activities.
- Responsible as a core member and lead on the AirLife teams, along with the project representative for Regulatory Affairs on assigned initiatives, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance by owning the following tasks:
- Defining and implementing the key processes that are the responsibility of the Regulatory Affairs department that includes specific inputs and outputs for the design & development, manufacturing, distribution and sale of AirLife products.
- Standardizing, deploying and implementation of regulatory information to ensure that supporting documentation is compliant with regulations & standards.
- Regular interaction with management and cross-functional teams to provide regulatory strategy at all stages of a product’s lifecycle.
- Driving improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
- Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
- Advising internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc to ensure regulatory strategy is aligned with company objectives.
OTHER RESPONSIBILITIES
- Uphold and embody AirLife’s values in all aspects of work.
- Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
- Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
- Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
- Contribute to building and maintaining a positive team environment.
- Assure all policies and guidelines are implemented and followed.
QUALITY POLICY
At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.
DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.
BENEFITS
AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.
Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.
COMPANY DESCRIPTION
At AirLife, we are dedicated to improving the quality of every breath. Excellence with Every Breath is not just a tag line, but the way we work and take care of our customers. With a mindset to evolve, innovate, and grow, we are a premier manufacturer of the highest-quality and market-leading breathing consumables. This growth philosophy has positioned us to increase our global footprint and business reach, impacting even more people around the world. Our expanding family of the most trusted brands offers a product portfolio that spans the continuum of care from first responder to home care, with safety, patient comfort, and clinical performance in mind. Collective expertise allows us to provide quality products and experiences to our patients, customers, and our people. Our values of Customer first, Differentiate with our People, Bias for Action, Continuous Improvement and Accountability define who we are and how we work. Join us!
POSITION SUMMARY
The Regulatory Affairs Specialist supports the preparation and maintenance of regulatory submissions, product registrations, and quality system documentation to ensure compliance with global medical device regulations. This includes documentation legalization for the support of international product registrations handled locally/physically and the coordination of document legalization with outside agencies and the ownership of the legalization process. This entry-level role provides administrative and technical assistance to the Regulatory Affairs Systems team.
POSITION QUALIFICATIONS
Knowledge, Skills, & Abilities:
- Basic knowledge of medical device regulations (21CFR), FDA regulations, EU MDD/MDR, other global laws and regulations and standards including ISO 14971, ISO 13485/MDSAP and related particular standards.
- Strong organizational skills and attention to detail.
- Effective written and verbal communication skills.
- Ability to manage multiple priorities and deadlines.
- Proficient computer skills in Microsoft Office.
- Experience with project deliverables and timelines for global regulatory submissions, preferred.
Level of Experience:
- 0–2 years of experience in regulatory affairs, specifically within the respiratory and anesthesia sector.
Level of Education:
- Bachelor’s degree preferably in Regulatory Affairs and/or an engineering or science related field or equivalent experience in the medical device and/or pharmaceutical industry.
Travel:
As the business needs. Local travel to complete physical document legalization required.
ESSENTIAL DUTIES AND RESPONSIBILITIES
- Assist in preparation of regulatory submissions and product registrations.
- Maintain regulatory files and databases.
- Support change control and quality system documentation.
- Provide administrative support during audits and inspections.
- Increase collaboration to address customer quality and delivery along with adherence to regulatory compliance.
- Formulate and provide support for regulatory policy into a regulatory strategic plan, while also being involved in developing, modifying, and executing company regulatory strategies and policies that affect immediate AirLife Business Group operations supporting go-to-market launches and activities.
- Responsible as a core member and lead on the AirLife teams, along with the project representative for Regulatory Affairs on assigned initiatives, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance by owning the following tasks:
- Defining and implementing the key processes that are the responsibility of the Regulatory Affairs department that includes specific inputs and outputs for the design & development, manufacturing, distribution and sale of AirLife products.
- Standardizing, deploying and implementation of regulatory information to ensure that supporting documentation is compliant with regulations & standards.
- Regular interaction with management and cross-functional teams to provide regulatory strategy at all stages of a product’s lifecycle.
- Driving improvement in regulatory aspects of the Quality System, developing processes and documenting procedures to ensure an effective Quality System.
- Ensuring compliance with the current regulatory procedures and updating the procedures when new regulatory requirements become effective.
- Advising internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc to ensure regulatory strategy is aligned with company objectives.
OTHER RESPONSIBILITIES
- Uphold and embody AirLife’s values in all aspects of work.
- Demonstrate accuracy and thoroughness in daily work; look for ways to improve and promote quality & safety.
- Inspire the trust of others; treat people with respect and dignity and embrace the value of diversity.
- Use time efficiently; perform job accurately, thoroughly, and conserve Company resources to improve profits.
- Contribute to building and maintaining a positive team environment.
- Assure all policies and guidelines are implemented and followed.
QUALITY POLICY
At AirLife, Quality is our promise. It is our commitment to customer satisfaction and our dedication to product excellence in an evolving global healthcare market. This promise is kept through a continuously improving and effective Quality Management System and compliance to Regulatory Requirements.
DEIA STATEMENT
At AirLife, we are committed to building a diverse workforce and an inclusive workplace that reflects the communities and customers we serve. We believe our philosophy on Diversity, Equity, Inclusion, and Advancement (DEIA) encourages excellence and equips us to serve an evolving global marketplace.
BENEFITS
AirLife offers a comprehensive benefits package, including medical, dental, and vision coverage, 401(k), paid time off, paid holidays, bereavement leave, Employee Assistance Program resources, and medical leave benefits, subject to applicable eligibility requirements. Certain positions may also be eligible for bonus, commission, or other incentive compensation.
Please note: The responsibilities outlined above are not exhaustive and may evolve over time. The role holder may be required to undertake additional duties as reasonably expected to meet the needs of the company.
See All 11 Regulatory Affairs Jobs in Michigan
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Find Regulatory Affairs JobsRegulatory Affairs Jobs by City in Michigan
Where Michigan roles are concentrated, by current openings.
Regulatory Affairs Job Market in Michigan
A snapshot from current Michigan openings, updated as new roles post.
Who's Hiring
Top Industries Hiring
- Insurance
- Medical Devices
What Michigan Employers Look For
The qualifications that appear most often in regulatory affairs jobs across Michigan.
- Bachelor's degree in life sciences, engineering, chemistry, or a related technical field
- Experience preparing FDA submissions including 510(k), PMA, or NDA documentation
- Familiarity with automotive regulatory standards such as FMVSS or CAFE compliance requirements
- Knowledge of ISO 13485, 21 CFR Part 820, or other quality management system regulations
- Strong technical writing skills for preparing regulatory documents and agency correspondence
- Relevant certification such as Regulatory Affairs Certification (RAC) from RAPS preferred
Regulatory Affairs Jobs in Michigan: Frequently Asked Questions
How do you become a regulatory affairs professional in Michigan?
Most regulatory affairs roles in Michigan require a bachelor's degree in a life science, engineering, or technical field, with a master's degree preferred for senior positions. There is no state-issued license specific to regulatory affairs in Michigan, but the Regulatory Affairs Certification (RAC) credential from the Regulatory Affairs Professionals Society is widely recognized and strengthens candidacy. Many Michigan employers in medical devices, pharmaceuticals, and automotive also value direct experience with FDA or NHTSA compliance frameworks.
How much do regulatory affairses make in Michigan?
Regulatory affairses in Michigan earn a median of about $77,390 a year, based on May 2025 Bureau of Labor Statistics wage data, ranging from around $46,290 for the lowest 10% to over $120,560 for the top 10%. Pay rises with experience, specialty, and employer.
Which companies hire regulatory affairs professionals in Michigan?
Employers hiring regulatory affairs professionals in Michigan right now include Stryker, AIRLIFE, and Getinge, based on current listings on Migrate Mate as of November 2026. Michigan's concentration of medical device manufacturers, pharmaceutical operations, and automotive OEMs means that regulatory affairs professionals here often have opportunities to move across multiple regulated industries without leaving the state.
Which Michigan cities have the most regulatory affairs jobs?
Lansing, Portage, and Grand Rapids have the most regulatory affairs openings in Michigan. Detroit and its surrounding suburbs drive volume through the automotive and manufacturing compliance sector, while Grand Rapids is home to a dense cluster of medical device and life sciences companies, and Ann Arbor draws openings from its pharmaceutical research and university-affiliated biotech ecosystem.
Are there remote regulatory affairs jobs in Michigan?
Yes, and more than most technical fields. Regulatory affairs is largely document-driven and analytical, making it well-suited to remote and hybrid arrangements. About 71% of regulatory affairs openings tied to Michigan are remote or hybrid as of November 2026, reflecting how broadly employers have adopted flexible models for this role. Submission writing, dossier review, and compliance consulting positions are the most consistently available in remote formats.
How can I get hired as a regulatory affairs professional in Michigan with little or no experience?
The most realistic entry path is through a quality assurance or regulatory coordinator role at a Michigan medical device or automotive supplier, where exposure to documentation and compliance processes builds foundational skills. Large Michigan employers such as Stryker and automotive Tier 1 suppliers often hire recent graduates into quality or compliance associate programs. Earning the RAC credential or completing a regulatory affairs certificate program strengthens early applications, as does lateral experience in quality engineering, clinical operations, or technical writing.
Where can I find and apply to regulatory affairs jobs in Michigan?
You can find and apply to regulatory affairs jobs in Michigan on Migrate Mate, which lists current openings across the state's medical device, pharmaceutical, and automotive sectors. Find roles that fit your background and apply directly to the employers posting them.
See All 11 Regulatory Affairs Jobs in Michigan
Find roles in Michigan that match your experience and apply in just a few clicks.
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