Regulatory Affairs Analyst Jobs in Michigan
Regulatory affairs analyst jobs in Michigan are concentrated in the state's life sciences, automotive, and manufacturing sectors, with demand at every level from entry-level associates to senior compliance leads. Most openings are in the Detroit metro, Grand Rapids, and Kalamazoo, where established employers like Pfizer, Stryker, and General Motors maintain significant regulatory and compliance functions. The most in-demand specializations are medical device submissions, FDA compliance, and pharmaceutical labeling and registration. See the openings below and apply to the ones that match your experience.
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Showing 5 of 11+ Regulatory Affairs Analyst 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 Analyst Jobs in Michigan
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Find JobsRegulatory Affairs Analyst Jobs by City in Michigan
Where Michigan roles are concentrated, by current openings.
Regulatory Affairs Analyst 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 analyst jobs across Michigan.
- Bachelor's degree in life sciences, engineering, regulatory affairs, or a related field
- Familiarity with FDA regulations, including 21 CFR Parts 820 and 211
- Experience preparing regulatory submissions such as 510(k)s, NDAs, or INDs
- Proficiency with regulatory information management systems and document control software
- Strong technical writing skills for drafting submissions, SOPs, and compliance reports
- Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society preferred
Regulatory Affairs Analyst Jobs in Michigan: Frequently Asked Questions
How do you become a regulatory affairs analyst in Michigan?
Most Michigan employers require a bachelor's degree in a life science, engineering, or health-related field as the foundation. Michigan does not issue a state-specific license for regulatory affairs analysts, but the Regulatory Affairs Certification from the Regulatory Affairs Professionals Society is widely recognized by Michigan's medical device, pharmaceutical, and automotive parts manufacturers as the key professional credential. Entry-level candidates typically start in quality assurance or documentation roles before moving into regulatory functions.
Which companies hire regulatory affairs analysts in Michigan?
Companies currently hiring regulatory affairs analysts in Michigan include Stryker, AIRLIFE, and Getinge, per current listings on Migrate Mate as of November 2026. Michigan's dense concentration of medical device manufacturers in the Kalamazoo corridor and automotive suppliers across the Detroit region means regulatory openings appear consistently throughout the year at both large corporations and specialized contract research organizations.
Which Michigan cities have the most regulatory affairs analyst jobs?
Lansing, Portage, and Grand Rapids account for the largest share of regulatory affairs analyst openings in Michigan. The Detroit metro leads because of its deep roster of automotive Tier 1 suppliers and health system compliance teams, while Grand Rapids and Kalamazoo draw openings from West Michigan's established medical device and pharmaceutical manufacturing base, which includes global-scale operations anchored there for decades.
Are there remote regulatory affairs analyst jobs in Michigan?
Yes, and more than many technical roles, because regulatory affairs work centers on document preparation, submission management, and written correspondence rather than on-site lab or production activity. About 71% of regulatory affairs analyst openings tied to Michigan are remote or hybrid as of November 2026, reflecting how much of the work can be performed outside a facility. Submission writing, labeling review, and regulatory intelligence monitoring are the functions most commonly offered as remote arrangements.
How can I get hired as a regulatory affairs analyst in Michigan with little or no experience?
The most realistic entry path is a quality assurance or regulatory affairs associate role at one of Michigan's mid-size medical device or pharmaceutical manufacturers, where hands-on exposure to document control and FDA submissions builds the foundational skills employers require. Large West Michigan device companies and Detroit-area automotive suppliers occasionally post rotational or associate programs for recent science and engineering graduates. Earning the RAC credential or completing a regulatory affairs certificate program gives candidates with limited experience a concrete credential that signals commitment to the field.
Where can I find and apply to regulatory affairs analyst jobs in Michigan?
You can find and apply to regulatory affairs analyst jobs in Michigan on Migrate Mate, which lists current openings across the state. Search for roles that match your experience level and specialization, then apply directly to the ones that fit. The listings are updated regularly, so check back as new Michigan postings appear from medical device, pharmaceutical, and manufacturing employers.
See All 11 Regulatory Affairs Analyst Jobs in Michigan
Find roles in Michigan that match your experience and apply in just a few clicks.
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