Senior Regulatory Affairs Specialist -FDA Medical

WACKER•Ann Arbor, MI

1d•Hybrid

About The Position

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, and 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. Prepares 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. 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).

Requirements

Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology
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
Ability to work legally in the United States on a permanent unrestricted basis

Nice To Haves

Master's Degree is preferred
Experience in Natural Health Products
Experience 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
Working knowledge of biocompatibility testing (USP Class VI & ISO 10993) and their applicability to different types of products for medical devices
Recognition of the differences between US and Canadian regulations
Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations
Serving as the liaison between Wacker and our Canadian Regulatory Agent
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
Experience in polymer chemistry is preferred

Responsibilities

Managing Wacker Chemical Corporation’s corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations
Refining Wacker’s corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, and healthcare applications
Evaluating and responding to incoming internal and external customer product compliance requests
Reviewing and accessing the chemical composition of Wacker product formulas and incoming raw material chemicals used in medical device, drug, and healthcare applications such as wound care
Preparing and submitting forms and applications for Wacker FDA Drug and Device Master Files
Preparing portions of Drug Master File (DMF) packages, establishing project work as needed with outside consultation
Preparing and submitting Medical Device Master File (MAF) packages and updates
Working with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations
Interpreting FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG)