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Fda Openings Jobs in Michigan (NOW HIRING)

... Openings: 1 About the Role Seeking a Medical Director to provide medical oversight at a plasma collection center, ensure regulatory compliance (FDA, CLIA/COLA, cGMP), and lead the Center Medical ...

An inclusive, open, and friendly environment focused on our employees and their success * Benefits ... Maintain cleanliness and organization of delivery vehicle and warehouse, adhering to all FDA ...

Delivery Driver - Medical Equipment

Big Rapids, MI · On-site

$15 - $18.50/hr

An inclusive, open, and friendly environment focused on our employees and their success * Benefits ... Maintain cleanliness and organization of delivery vehicle and warehouse, adhering to all FDA ...

Delivery Driver - Medical Equipment

Kalamazoo, MI · On-site

$16.50 - $20.25/hr

An inclusive, open, and friendly environment focused on our employees and their success * Benefits ... Maintain cleanliness and organization of delivery vehicle and warehouse, adhering to all FDA ...

Delivery Driver - Medical Equipment

Plymouth, MI · On-site

$16.75 - $20.50/hr

An inclusive, open, and friendly environment focused on our employees and their success * Benefits ... Maintain cleanliness and organization of delivery vehicle and warehouse, adhering to all FDA ...

Warehouse Inventory Coordinator

Kalamazoo, MI · On-site

$17.25 - $22.75/hr

Open-ended Location: Kalamazoo, MI Our client is seeking a Service Inventory Coordinator to join ... Experience working with FDA regulated products (Medical Device/IVD preferred)(pharmaceutical or ...

New

This role supports compliance with FDA, ISO 13485, and applicable regulatory requirements through ... opening. Envista will not pay a fee to any Agency that does not have such agreement and written ...

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Fda Openings information

What are the key skills and qualifications needed to thrive in FDA job openings, and why are they important?

To thrive in FDA job openings, candidates typically need a strong background in science, regulatory affairs, and analytical skills, often with a relevant degree in biology, chemistry, pharmacy, or related fields. Familiarity with regulatory databases, submission systems (such as eCTD), and certifications like RAC (Regulatory Affairs Certification) are highly valued. Attention to detail, effective communication, and the ability to work collaboratively are essential soft skills for success. These competencies ensure regulatory compliance, thorough review of submissions, and effective teamwork in safeguarding public health.

What are some common challenges faced by professionals starting in FDA roles, and how can applicants prepare for them?

Professionals beginning their careers at the FDA often encounter challenges such as adapting to complex regulatory frameworks, working with cross-disciplinary teams, and managing the pace of policy changes. To prepare, applicants should familiarize themselves with FDA guidelines and regulatory processes, develop strong communication skills to collaborate effectively with scientists, regulators, and industry representatives, and stay updated on current public health issues. Proactive learning and seeking mentorship within the organization can also ease the transition and foster professional growth.

What are FDA openings?

FDA openings refer to job opportunities or vacancies at the U.S. Food and Drug Administration (FDA). The FDA is a federal agency responsible for protecting public health by regulating food, drugs, medical devices, and other related products. These openings span a wide range of roles, including scientists, inspectors, analysts, administrative professionals, and more. Candidates can find current job listings and application instructions on the official USAJOBS website and the FDA’s careers page. Working at the FDA offers the chance to contribute to public health and safety at a national level.

What are popular job titles related to Fda Openings jobs in Michigan?

For Fda Openings jobs in Michigan, the most frequently searched job titles are:

What cities in Michigan are hiring for Fda Openings jobs?

Cities in Michigan with the most Fda Openings job openings:

Medical Director

Ubertal Inc

Jackson, MI • On-site

Contractor

Re-posted 11 days ago


Job description

Job Title: Medical Director (Center Physician)

Location: Jackson, MI (Onsite; limited remote tasks may be permitted)
Job Type: Contract | Full-Time (40 hours/week)
Duration: 24 months (potential multi-year extension)
Openings: 1

About the Role
Seeking a Medical Director to provide medical oversight at a plasma collection center, ensure regulatory compliance (FDA, CLIA/COLA, cGMP), and lead the Center Medical Staff. The role serves as primary physician for regulatory reporting, oversees donor suitability and incident reviews, and supports training, quality, and governance activities.

Key Responsibilities

  • 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, technical or clinical consultant); ensure CLIA/COLA training, proficiency testing (hematocrit, total protein), and standardization logs are completed.

  • Uphold cGMP standards in partnership with center management and quality; be onsite for agreed hours.

  • Provide medical oversight and training to Medical Staff Associates (MSAs) and physicians; evaluate newly trained MSAs and recommend certification completion.

  • Review and sign MSA notebooks weekly; sample-review screening evaluations and unsuitable test result communications.

  • Hold monthly meetings with MSAs; document discussions; participate in weekly center leadership check-ins and Quality Assurance Team activities.

  • Advise on donor suitability for serial plasmapheresis; conduct confidential donor interviews; respond to staff inquiries on donor eligibility.

  • Review/sign moderate and severe medical incident reports before donor re-entry; review abnormal/normal SPE results and approve returns to donate as appropriate.

  • Oversee medical supplies and emergency equipment; maintain strict confidentiality of all records.

  • Support immunization and hyper-immune programs where applicable (qualifications, approvals, presence during immunizations, and monthly reporting).

  • Perform center physician duties as needed: notify donors of unsuitable results, perform screening medical evaluations, determine initial/continued donor suitability, and explain informed consent.

  • Perform additional medically related services as requested.

Required Qualifications

  • MD or DO from an accredited medical or osteopathic school.

  • Active, unrestricted medical license in Michigan (must be maintained).

  • Minimum one year of residency training (MD or DO).

  • Knowledge of infectious disease markers (e.g., HIV, HBV, HCV, syphilis) and donor health/safety standards.

  • Experience in regulated clinical/laboratory environments (FDA, CLIA/COLA, cGMP).

  • Strong leadership, documentation, and communication skills; ability to train and mentor clinical staff.

Preferred Qualifications

  • Lab Director qualifications preferred.

  • Prior experience in plasma/blood collection operations.

  • Demonstrated experience serving in CLIA laboratory leadership/consultant roles.

  • Background in quality assurance participation and regulatory audits.

Key Skills
Center Physician Oversight | FDA/CLIA/COLA Compliance | cGMP | Donor Suitability | Medical Staff Training | Incident Review | SPE Result Review | Quality Governance | Confidentiality

Interview & Work Details

  • Interview Format: Webcam or in-person.

  • Schedule: Full-time; onsite presence for agreed hours. Limited remote activities may be permitted per policy.