Senior Regulatory Affairs Specialist -FDA Medical

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.