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Live In Fda Scientist Jobs in Michigan (NOW HIRING)

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Live In Fda Scientist information

What is the difference between Live In Fda Scientist vs Fda Reviewer?

AspectLive In Fda ScientistFda Reviewer
Required credentialsBachelor's or Master's in Life Sciences, relevant experienceSimilar credentials, often with advanced degrees
Work environmentOn-site, often in government or research facilitiesOffice-based, reviewing submissions at FDA headquarters or regional offices
Employer and industry usageFederal government, regulatory scienceFederal government, regulatory review
Common search intentJob duties, qualifications, work conditionsComparison of roles, responsibilities, career path

The Live In Fda Scientist and Fda Reviewer roles both require scientific expertise and federal employment credentials. While the Live In Fda Scientist often involves conducting research and scientific analysis on-site, the Fda Reviewer primarily focuses on evaluating regulatory submissions and documentation. Both roles are integral to FDA operations, but they differ in daily tasks and work environment, with the scientist more research-oriented and the reviewer more review-focused.

What are the key skills and qualifications needed to thrive as a Live-In FDA Scientist, and why are they important?

To thrive as an FDA Scientist, you need a strong background in life sciences or chemistry, typically with an advanced degree (MS or PhD) and experience in research or regulatory affairs. Familiarity with laboratory instrumentation, data analysis software, and FDA regulatory systems is essential, and certifications like RAC (Regulatory Affairs Certification) can be advantageous. Attention to detail, critical thinking, and excellent communication skills help you interpret data accurately and collaborate effectively with multidisciplinary teams. These skills ensure scientific integrity, regulatory compliance, and the advancement of public health through safe and effective products.

What is a Live In FDA Scientist?

A Live In FDA Scientist typically refers to a regulatory scientist who works for the U.S. Food and Drug Administration (FDA) and may be involved in on-site or continuous monitoring of studies, often in clinical or laboratory settings. Their role includes evaluating scientific data, ensuring compliance with federal regulations, and overseeing the safety and efficacy of products such as drugs, biologics, or medical devices. Live-in positions might be required for research facilities needing 24/7 oversight, although such roles are rare and specialized. These scientists play a crucial role in public health by supporting the FDA’s mission to protect consumers.

What are some unique challenges faced by a Live-In FDA Scientist, and how can they be managed?

A Live-In FDA Scientist often works in environments such as research facilities or clinical trial sites where on-site presence is essential. This setup can present challenges like maintaining work-life balance, adapting to extended hours, and managing confidentiality due to the sensitive nature of ongoing research. Successful candidates typically develop strong time management skills, set clear personal boundaries, and foster open communication with team members to ensure both professional responsibilities and personal well-being are balanced. Collaboration with multidisciplinary teams is frequent, and adaptability is key to thriving in this dynamic role.
Live In Fda Scientist jobs near you

Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements

Wacker Chemie AG

Ann Arbor, MI • On-site

Full-time

Medical, Dental, Vision, Retirement, PTO

Posted 8 days ago

Job description

Job Title: Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements
Job Location (Short): Ann Arbor, MI, USA, 48108
Posting Start Date: 6/19/26
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, Cosmetics, Dietary Supplements.
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.

What do we offer?
WACKER is an equal opportunity employer committed to diversity, equity, inclusion, and sustainability. We are innovators, researchers, and pioneers and we believe that our individual differences are our collective strength. We foster an inclusive environment that promotes individuality, celebrates diversity, and builds cohesive teams. Together, we create exceptional value for our employees, our customers, and our communities by creating a culture of inclusion and equity that enables, empowers, and values our diverse contributions.
WACKER strives to reward its employees in a fair and equitable manner. Our Total Rewards Package considers employee wellbeing and is comprised of compensation, benefits, work-life balance, performance & recognition, and career development.
  • Compensation and Incentive plans
  • Medical, Dental, and Vision Insurance effective day 1
  • Paid Time Off in addition to personal days and holidays
  • Paid parental leave
  • Wellbeing fund
  • Flexible hybrid work arrangements
  • 401(k) with company match
  • Education Assistance Program
  • Career development and advancement opportunities
  • Support for Community Involvement

We are looking forward to your online application at www.wacker.com.
Reference Code: 31073
#LI-LGI
The information contained herein is not intended to be an all-inclusive list of the duties and responsibilities of the job, nor are they intended to be an all-inclusive list of the skills and abilities required to do the job.
A minimum requirement for this US-based position is the ability to work legally in the United States on a permanent unrestricted basis. Visa sponsorship is not available for this position, including for any type of US permanent residency (e.g., for a green card).
WACKER is proud to be an Equal Opportunity/Affirmative Action Employer, making decisions without regard to race, color, religion, creed, sex, sexual orientation, gender identity, marital status, national origin, age, veteran status, disability, or any other protected class.

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