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Fda Jobs in Michigan (NOW HIRING)

Mitovation

Be Seen First

Systems Engineer - Medical Device Company

Ann Arbor, MI · On-site

$110K - $140K/yr

The technology originated from mitochondrial biology research at Wayne State University and the University of Michigan and has progressed through an active FDA Investigational Device Exemption (IDE ...

Actalent

Lab Assistant

Kalamazoo, MI · On-site

Follow cGMP and FDA regulatory requirements and adhere to all standard operating procedures and safety guidelines. * Look for and implement small improvements in lab processes, organization, and ...

Actalent

Lab Assistant

Kalamazoo, MI · On-site

Follow cGMP and FDA regulatory requirements and adhere to all standard operating procedures and safety guidelines. * Look for and implement small improvements in lab processes, organization, and ...

Able Medical Devices

CNC Setup Technician

Marquette, MI

$19.75 - $27.25/hr

It's precision medical device work in an ISO 13485-certified, FDA-registered environment, with a full-time schedule and relocation assistance available. What you'll be doing * Set up CNC equipment ...

Able Medical Devices

CNC Operator

Marquette, MI · On-site

$19.75 - $27.25/hr

As a CNC Operator, you will run production and prototype work on CNC machining centers, Swiss turning centers, and Wire EDM equipment in an ISO 13485-certified, FDA-registered production environment.

Biovire

Director, Validation

Brighton, MI · On-site

$100K - $120K/yr

The position will also represent Biovire as the senior Validation SME during FDA and other regulatory inspections and client audits, including presenting and defending validation strategies and ...

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Fda information

What does an FDA 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 are the key skills and qualifications needed to thrive as an FDA 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 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 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 qualifications do you need to work for the Food and Drug Administration?

To work for the Food and Drug Administration (FDA), candidates typically need a bachelor's degree in a relevant field such as science, engineering, or public health. For certain positions, advanced degrees or specialized certifications may be required, along with relevant work experience and knowledge of regulatory processes and compliance standards.

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 August 2026, with employment types broken down into 93% Full Time, 5% Part Time, and 2% Contract. Highlights an 100% In-person job distribution.

Senior Professional Regulatory Affairs - Lifecycle Management - Medicines

Perrigo Company plc

Allegan, MI • On-site

Full-time

Re-posted 2 days ago

Perrigo rating

8.5

Company rating: 8.5 out of 10

Based on 57 frontline employees who took The Breakroom Quiz

19th of 86 rated pharmaceutical

Job description

At Perrigo, we are driven by our mission to Makes Lives Better Through Trusted Health and Wellness Solutions, Accessible to All. We are proud to be a Top 10 player in the European Consumer Self-Care market and the largest U.S. store brand provider of over the counter and infant formula. Dedicated to providing The Best Self-Care for Everyone, we are the people behind the brands you trust. We are Opill, Compeed, Solpadeine, NiQuitin, and many more. We Are Perrigo. We are committed to enhancing the wellbeing of our colleagues and consumers alike. We pride ourselves on fostering an inclusive, collaborative culture where each person can experience a sense of belonging.

Join us on our One Perrigo journey as we evolve to win in self-care.

Description Overview

We are excited to recruit a Senior Professional within the Medicines classification team for Lifecycle Management, you will play a key role in delivering Perrigo's regulatory strategy across the product lifecycle. You will support the development and execution of regulatory strategies, ensuring the consistent delivery of high-quality regulatory outcomes across a diverse and complex portfolio. 

You will be responsible for managing lifecycle management activities, overseeing the preparation, submission, and maintenance of approved applications and regulatory dossiers in line with FDA requirements, relevant ICH expectations, other applicable health authority requirements, and business priorities. You will proactively identify risks, support mitigation planning, and ensure timely, compliant submissions that help maintain supply continuity, consumer safety, and market access. 

You will provide clear direction, support capability development, and foster a culture of accountability and continuous improvement. You will manage priorities across multiple activities, ensuring effective execution and alignment with departmental and organisational goals. 

Working closely with cross-functional stakeholders-including Quality, Safety, Supply Chain, and R&D-you will contribute regulatory expertise to change management and business initiatives. You will help translate regulatory requirements into practical, actionable plans that support product maintenance, compliance, and portfolio optimisation. 

You will also contribute to the continuous improvement of Regulatory Affairs processes and ways of working, helping to drive efficiency, consistency, and scalability across lifecycle activities. Through your role, you will support Perrigo's ability to meet evolving regulatory requirements while maintaining high standards of compliance and quality. 

This role offers the opportunity to make a meaningful impact within the Regulatory Affairs organisation-supporting product availability and regulatory performance while developing your leadership and technical expertise in a dynamic, global environment.

Scope of the Role
  • Leads complex, high-impact lifecycle regulatory projects and workstreams across multiple drug products, the US market and/or global markets, or regulatory pathways. 
  • Provides strategic regulatory leadership for significant post-approval supplements and annual reportable changes, remediation, and compliance risks, ensuring lifecycle delivery protects compliance posture, approved application commitments, and supply continuity. 
  • Acts as a recognised subject matter expert, mentors others, and drives governance and continuous improvement within the LCM team.
  • Leads complex change programmes such as site transfers, CMC and quality-related post-approval changes, renewals, remediation, or other high-risk lifecycle activities for NDA, ANDA, OTC monograph, and/or related drug product portfolios. 
  • Operates with high autonomy and is accountable for recommendations and technical direction on complex topics within delegated authority. 
  • Acts as senior individual contributor and mentor, leading cross-functional governance with impact across multiple products or portfolio workstreams. 

Strategic Lifecycle Leadership 

  • Lead assessment and management of complex and high-risk post-approval changes across the US market and/or global markets, defining data needs, appropriate FDA reporting category, submission strategy, and dossier updates. 
  • Provide strategic oversight of lifecycle dossiers, technical documentation, and inspection readiness; set and coach high standards for right-first-time quality. 
  • Lead complex lifecycle submissions across products and markets, including post-approval supplements, annual reportable changes, renewals, remediation, escalated RFIs, and deficiency responses. 
  • Approve or recommend change approach, appropriate FDA reporting category, and submission strategy within delegated remit, and escalate major compliance or supply risks through governance. 

Risk, Governance & Compliance 

  • Anticipate and mitigate significant regulatory risks and lead issue resolution for compliance gaps or supply disruption threats. 
  • Lead cross-functional risk reviews, remediation planning, and governance forums with Quality, Supply, Safety, R&D, Manufacturing, RegOps, and Cluster RA. 
  • Drive cross-functional improvements to lifecycle processes and systems, define implementation steps, and embed standard work. 

Leadership & Influence 

  • Act as regulatory lead for complex health authority interactions, including FDA as applicable, and coordinate consistent evidence-based responses. 
  • Coach and quality review the work of D2/D3 colleagues and embed Good Documentation Practice within the team. 
  • Influence senior stakeholders and cross-functional teams without formal authority to achieve aligned decisions and timely delivery. 
Experience Required
  • Typically 5-8+ years in Regulatory Affairs with proven experience leading complex regulatory projects and authority interactions; relevant scientific or technical degree preferred. 
  • Sustained performance in complex lifecycle roles or similar experience considered. 
  • Demonstrated capability in strategic lifecycle thinking, governance, and coaching others. 

Benefits
We believe our people are our greatest asset. Alongside competitive compensation, we offer benefits tailored to supporting you and your family, as well as career development opportunities to ensure you feel valued and supported, both professionally and personally.

Find out more about Total Rewards at Perrigo. 

Hybrid Working Approach
We love our offices and the setting they provide for in-person collaboration and celebration. But we also appreciate the opportunity to work remotely can energise you too, so we promote flexibility with the ability to work two days a week from home in many roles.

We are proud to be included in the Forbes list of "America's Best Employers by State 2024". Find out more here

Applicants please note: To apply to this position please click the APPLY button at the bottom of the application.  (The SAVE button will only save your profile information but not submit an application for this open position.) All application materials, including resumes and CVs, must be submitted in English. Thank you.

We are an equal opportunity employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, disability, status as a protected veteran, or other characteristics protected by law.  #weareperrigo

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