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Fda Jobs in Michigan (NOW HIRING)

Ubertal Inc

Medical Director

Saginaw, MI · On-site

Oversee medical compliance and quality practices per FDA and CLIA regulations. * Serve as Laboratory Director and ensure CLIA/COLA certification and training compliance. * Supervise and train Medical ...

Getinge

Senior Manager, Regulatory Affairs

Fraser, MI · On-site

S. (FDA), EU MDR (2017/745), and applicable global regulations, enabling innovation and growth while maintaining regulatory integrity throughout the product lifecycle. This leader collaborates with ...

Chobani

Process Authority

Norton Shores, MI · On-site

Prepare the information required for filing the schedule process with FDA for both retorted and aseptic processes and submit with FDA ensuring compliance with 21 CFR 113 (Low-Acid Canned Foods ...

Chobani

Process Authority

Norton Shores, MI

Prepare the information required for filing the schedule process with FDA for both retorted and aseptic processes and submit with FDA ensuring compliance with 21 CFR 113 (Low-Acid Canned Foods ...

Ubertal Inc

Medical Director

Jackson, MI · On-site

Serve as primary physician for FDA reporting; monitor medical compliance with applicable federal/state regulations, including Title 21 CFR. * Fulfill or delegate CLIA roles (laboratory director ...

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Fda information

Why is the FDA understaffed?

The FDA often faces staffing shortages due to limited budgets, increasing workload from expanding regulatory responsibilities, and lengthy hiring processes. These factors can delay the recruitment and retention of qualified personnel, impacting the agency's ability to efficiently oversee food, drugs, and medical devices.

Is it hard to get hired by the FDA?

Getting hired by the FDA can be competitive due to the specialized nature of the roles and the high standards for education, experience, and security clearances. Candidates often need relevant degrees, such as in science or public health, and may undergo rigorous background checks and assessments. Strong technical skills and knowledge of regulatory processes can improve chances of employment.

What are some typical challenges faced by professionals working at the FDA, and how can they be managed?

Professionals at the FDA often navigate complex regulatory requirements, tight deadlines, and the need to balance public health priorities with industry innovation. Collaborating across multidisciplinary teams and staying updated on evolving scientific data are essential parts of the role. Adapting to frequent changes in policy and handling high volumes of submissions can be demanding, but leveraging strong communication skills and seeking mentorship within the agency can help manage these challenges effectively.

What are the key skills and qualifications needed to thrive as an FDA (U.S. Food and Drug Administration) Regulatory Affairs Specialist, and why are they important?

To thrive as an FDA Regulatory Affairs Specialist, you need a strong background in life sciences, regulatory guidelines, and compliance, usually supported by a relevant degree such as pharmacy, biology, or chemistry. Familiarity with regulatory submission systems, FDA regulations (such as 21 CFR), and certifications like RAC (Regulatory Affairs Certification) are highly beneficial. Attention to detail, strong analytical thinking, and effective communication skills help professionals navigate complex regulations and collaborate with cross-functional teams. These competencies ensure that products meet legal requirements and safety standards, facilitating successful approvals and market access.

What does an FDA (Food and Drug Administration) professional do?

An FDA professional works for the U.S. Food and Drug Administration, a federal agency responsible for protecting public health by ensuring the safety and efficacy of drugs, medical devices, food, cosmetics, and other products. Their roles can include reviewing and approving new drugs and medical devices, conducting inspections, enforcing regulations, and providing guidance to industries. FDA professionals may also work in research, policy development, and public outreach to ensure that products meet regulatory standards and are safe for consumer use.

What is the highest paying job at the FDA?

The highest paying jobs at the FDA are typically senior leadership roles such as the Commissioner of Food and Drugs or Deputy Commissioner, which can have salaries exceeding $200,000 annually. These positions require extensive experience, advanced degrees, and often involve overseeing regulatory policies and organizational management.

How do I get into the FDA?

To work at the FDA, candidates typically need a relevant bachelor's degree in fields like science, engineering, or healthcare, along with experience in regulatory or scientific roles. Positions often require passing background checks and may involve specialized training or certifications depending on the role. Applying through USAJOBS and demonstrating knowledge of FDA regulations and policies is essential.

What is the difference between Fda vs Food Scientist?

AspectFdaFood Scientist
Required CredentialsTypically a degree in health, science, or related field; certifications varyBachelor's or master's in food science, microbiology, or related
Work EnvironmentRegulatory agencies, laboratories, inspection sitesFood manufacturing facilities, laboratories, research settings
Employer & Industry UsageU.S. Food and Drug Administration, government agenciesFood companies, research institutions, government agencies
Common Search & Comparison IntentUnderstanding regulatory roles, compliance, and enforcementFood safety, product development, research

While both Fda professionals and Food Scientists work within the food industry, Fda roles focus on regulation, compliance, and enforcement of food safety laws, often within government agencies. Food Scientists primarily engage in research, product development, and ensuring food quality in manufacturing settings. The two careers overlap in food safety knowledge but differ in their primary responsibilities and work environments.

What are the most commonly searched types of Fda jobs in Michigan? The most popular types of Fda jobs in Michigan are:
What are popular job titles related to Fda jobs in Michigan? For Fda jobs in Michigan, the most frequently searched job titles are:
What job categories do people searching Fda jobs in Michigan look for? The top searched job categories for Fda jobs in Michigan are:
What cities in Michigan are hiring for Fda jobs? Cities in Michigan with the most Fda job openings:
Fda jobs near you
Infographic showing various Fda job openings in Michigan as of June 2026, with employment types broken down into 87% Full Time, and 13% Contract. Highlights an 100% In-person job distribution.

Senior Regulatory Affairs Specialist -FDA Medical

Wacker Chemie AG

Ann Arbor, MI • On-site

Full-time

Posted 12 days ago

Job description

Ann Arbor, MI, USA, 48108
Posting Start Date: 6/1/26
Do you want to take responsibility and make a difference with your work? With your expertise, we can achieve great goals together. We are WACKER - Reliable. Determined. Ambitious. As one of the world's most research-intensive chemical companies, we've been making countless products that are an integral part of your everyday life possible for over 100 years. From vegan food to resource-efficient buildings to solar cells, we develop sustainable solutions that change the future.
To strengthen our team in Ann Arbor,
we are looking for you as a(n) Senior Regulatory Affairs Specialist -FDA Medical.
Senior Regulatory Affairs Specialist-FDA Medical
  • Responsible for managing Wacker Chemical Corporation's corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
  • Responsible for refining Wacker's corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications.
  • Evaluates and responds to incoming internal and external customer product compliance requests and will review and access the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
  • Prepars and submits forms and applications for Wacker FDA Drug and Device Master Files. Prepare portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation and preparing and submitting Medical Device Master File (MAF) packages and updates.
  • Experience in Natural Health Products, as well as in the process for filing new drug ingredient notifications and the technical data required by the agency, even if the customer is doing the actual filing.
  • Awareness of drug facility registration requirements would be useful. For medical devices, working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products.
  • Recognition of the differences between US and Canadian regulations. Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent
  • Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
  • Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG). Familiarity with appropriate FDA cGMP or other applicable guidance such as the USP Good Manufacturing Processes for Bulk Pharmaceutical Excipients and FDA Active Pharmaceutical Ingredient (API) regulatory approval process.

Requirements:
  • Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.
  • 7+ years of experience preferred.
  • Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.
  • Knowledge and experience in 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
  • Strong leadership, interpersonal and problem-solving skills.
  • Experience working in cross-functional teams.
  • Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture.
  • Experience in polymer chemistry is preferred.

Apply