About this role
<div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><img src="https://performancemanager5.successfactors.eu/wackerchem/Jobs_Header_English_blue_970x400.jpg" style="height:200.0px;width:970.0px"></span></span></div> <div> </div> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">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.</span></span></div> <div> </div> <div style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">To strengthen our team in <b><b>Ann Arbor</b></b>,</span></span></div> <div style="text-align:center"><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">we are looking for you as a(n) <b><b>Senior Regulatory Affairs Specialist -FDA Medical, Cosmetics, Dietary Supplements</b></b>.</span></span></div> <p> </p> <p><b><span style="font-size:10.0pt"><span style="font-family:'Arial', sans-serif"><span style="color:black">Senior Regulatory Affairs Specialist-FDA Medical</span></span></span></b> </p> <ul> <li><span style="font-size:12.0px"><span style="font-family:'Arial', sans-serif"><span>Responsible for managing Wacker Chemical Corporation’s corporate compliance program for Medical and Drug applications per the requirements of the 21 CFR regulations</span></span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">Responsible for refining Wacker’s corporate procedures and strategy regarding FDA compliance toward medical device components, drugs, ad healthcare applications. </span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">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</span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">Prepars and submits forms and applications for Wacker FDA Drug and Device Master Files. <span style="color:black">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.</span> </span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">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. </span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">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. </span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif">Recognition of the differences between US and Canadian regulations. <span style="color:black">Familiarity with Canadian Medical Device regulations, Drug regulations, and Cosmetic regulations and serving as the liaison between Wacker and our Canadian Regulatory Agent</span></span></span></li> <li><span style="font-size:12.0px"><span style="font-family:'Times New Roman', serif"> <span>Work with other departments to ensure compliance to </span></span><span style="font-family:'Arial', sans-serif">Good Manufacturing </span><span style="font-family:'Times New Roman', serif"><span>(GMP), FDA-CFR, ISO, Responsible Care standards and regulations. </span></span></span></li> <li><span style="font-size:12.0px"><span style="font-family:Arial, sans-serif"><span style="font-family:'Times New Roman', serif"><span>Will interpret FDA regulations and utilizing government and 3rd party databases such as the FDA Electronic Submission Gateway (ESG).</span> 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. </span></span></span></li> </ul> <p><b>Requirements</b>: </p> <ul> <li><span style="font-size:12.0px">Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is preferred.</span></li> <li><span style="font-size:12.0px">7+ years of experience preferred.</span></li> <li><span style="font-size:12.0px">Strong organizational and professional skills with extensive knowledge of FDA regulations and reading and interpreting legal documents.</span></li> <li><span style="font-size:12.0px">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.</span></li> <li><span style="font-size:12.0px">Strong leadership, interpersonal and problem-solving skills.</span></li> <li><span style="font-size:12.0px">Experience working in cross-functional teams.</span></li> <li><span style="font-size:12.0px">Experience working with leadership and team members to ensure a safety, quality and environmentally conscience culture. </span></li> <li><span style="font-size:12.0px">Experience in polymer chemistry is preferred.</span></li> </ul> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"> </span></span></div> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif"><b>What do we offer? </b></span></span></div> <div> </div> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">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. </span></span></div> <div> </div> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">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.</span></span></div> <div> </div> <ul> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Compensation and Incentive plans</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Medical, Dental, and Vision Insurance effective day 1</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Paid Time Off in addition to personal days and holidays</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Paid parental leave</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Wellbeing fund</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Flexible hybrid work arrangements</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">401(k) with company match</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Education Assistance Program</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Career development and advancement opportunities</span></span></div> </li> <li> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">Support for Community Involvement</span></span></div> </li> </ul> <div> </div> <div><span style="font-size:14.0px"><span style="font-family:Arial, Helvetica, sans-serif">We are looking forward to your online application at www.wacker.com.<br> Reference Code: 31073 </span></span></div> <div>#LI-LGI </div> <div><span style="font-size:10.0px"><span style="font-family:Arial, Helvetica, sans-serif">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.</span></span></div> <div><span style="font-size:10.0px"><span style="font-family:Arial, Helvetica, sans-serif">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).</span></span></div> <div><span style="font-size:10.0px"><span style="font-family:Arial, Helvetica, sans-serif">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.</span></span></div>