Top 665 Technical specialist Jobs in Novi Mi

Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements
Wacker Chemie AG —Ann Arbor, MI
- Online Application
- Bachelor of Science
- Office
- Master's degree
- Paid parental leave
- Paid holidays
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Oak Electric Service, Inc —Waterford, MI
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Fuel System Valve Technical Expert
YAPP USA Automotive Systems, Inc. —Romulus, MI
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HVAC Technician Specialist
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Fine Art Restoration Specialist
PF Galleries —Troy, MI
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Mortgage Servicing Platform IT Specialist
United Wholesale Mortgage —Pontiac, MI
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Specialist - Operations, On-Highway Truck Parts
MacAllister Machinery —Novi, MI
- Full-time
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Warranty Specialist
GENERAL RV CENTER —Wixom, MI
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Technical Sales Specialist Wood Veneer
Oakwood Veneer Company —Troy, MI
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5d
Professional Dog Groomer
PetSuites —Novi, MI
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Diagnostic Support Specialist
Technology Resource Group —Auburn Hills, MI
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4d
Environmental Safety and Health Specialist
Technology Resource Group —Auburn Hills, MI
- 5 years
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Supply Chain Specialist
Advantage Technical —Auburn Hills, MI
- Up to $37.02 an hour
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3d
Virtual Automotive Diagnostic Software Support Specialist
HCL Technologies —Farmington Hills, MI
- $20 an hour
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12d
Dispenser Install Specialist
EVERGREEN INSTALL SERVICES —Canton, MI
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IT Help Desk Specialist
The Medical Team —Livonia, MI
- From $16 an hour
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3d
IT Support Specialist
Ervin Industries, Inc. —Ann Arbor, MI
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6d
SUD Data Collection Specialist
National Council on Alcoholism and Drug Depedence,Greater Detroit Area —Detroit, MI
- $18.94 - $22.81 an hour
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Compliance Specialist
Jefferson Wells —Detroit, MI
- Contract
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Electronic Category Management Professional
Schaeffler Group —Auburn Hills, MI
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6d

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

Wacker Chemie AG -
Ann Arbor, MI

Apply Now

Job Details

Benefits

Paid parental leave
Paid holidays
Health insurance
Dental insurance
Paid time off
Parental leave
Vision insurance
401(k) matching
Opportunities for advancement

Qualifications

Legal analysis
Drug regulation
Bachelor's degree
Biomedical regulatory compliance
Cross-functional collaboration
Cross-functional communication

Full 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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Refine Your Search

technical specialist jobs in novi mi

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

Sales Operations Specialist

Fuel System Valve Technical Expert

HVAC Technician Specialist

Fine Art Restoration Specialist

Mortgage Servicing Platform IT Specialist

Specialist - Operations, On-Highway Truck Parts

Warranty Specialist

Technical Sales Specialist Wood Veneer

Professional Dog Groomer

Diagnostic Support Specialist

Environmental Safety and Health Specialist

Supply Chain Specialist

Virtual Automotive Diagnostic Software Support Specialist

Dispenser Install Specialist

IT Help Desk Specialist

IT Support Specialist

SUD Data Collection Specialist

Compliance Specialist

Electronic Category Management Professional

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