Regulatory Affairs Specialist-FDA Medical

Our world needs ideas! As one of the world’s most research-intensive chemical companies, we have been developing leading solutions for numerous sectors – from construction to photovoltaics and cosmetics to rubber – for over 100 years. We have a global presence with production sites on three continents and about 14,500 employees from 70 nations.

WACKER SILICONES is one of the world’s biggest silicone manufacturers with silicone-based system solutions and over 3,000 different products. At our Ann Arbor site, we are currently looking for a ​Regulatory Affairs Specialist-FDA Medical​ to join our growing team.

Regulatory Affairs Specialist-FDA Medical  

• This position is responsible for leading FDA regulatory product compliance reviews for Medical Device, Drugs, and Healthcare applications per the requirements of the 21 CFR regulations.  
• Responsible for regulatory affairs reviews and formulas and data submissions to the US FDA in relation to support of Medical Device, Drug, and Healthcare applications.
• Evaluate and respond to incoming internal and external customer product compliance requests and will also perform regulatory reviews of Wacker product formulas and incoming chemicals.
• Experience in preparing and submitting forms and applications for FDA approvals and collecting and preparing the information needed for submitting Drug and Device Master Files.
• 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.
• Work with other departments to ensure compliance to Good Manufacturing (GMP), FDA-CFR, ISO, Responsible Care standards and regulations.
• Must have experience in interpreting government 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.
• 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.
   

Requirements: 

• Bachelor of Science Degree in Biology, Chemistry, Toxicology, or Pharmacology. Master's Degree is 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.
• 5+ years of experience preferred.
• Strong knowledge of 21 CFR regulations on Drugs (API, OTC, Excipient), Veterinary products, Medical Devices, and products which can cross categories, like transdermal patches.
• Good knowledge of regulations on new drug ingredients, facility and product registration, biologics, as well as generic, and orphan drug classifications.
• Knowledge regarding cGMP- Current Good Mfg. Practices and GDP-Good Documentation Practices.
• Good presentation and computer skills such as, Microsoft Office skills (Word, Excel, PowerPoint), SAP, and Sharepoint.
• Ability to research, learn and properly apply information, such as standards/regulations, and guidance documents, without direct supervision.
• Excellent listening, written and verbal communication skills, including persuasive skills.

Life at Wacker:
Wacker is an equal opportunity employer that is committed to diversity, equity, and inclusion. We believe that our individual differences are our collective strength. We encourage our employees to be their authentic selves and desire team members that share these interests. You will be valued for your contributions and perspectives as we continue to grow together. Your career is important to us, and we want to foster a mutually beneficial relationship where you feel heard, understood, and fulfilled. We consider our employees’ overall health and satisfaction when creating a benefits package. Below are some of the additional incentives our employees enjoy.
 

• Medical, Dental, and Vision Insurance effective Day 1
• 401(k) with company match
• Tuition Reimbursement
• Advancement Opportunities
• Education Assistance Program
• Paid Time Off in addition to personal days and holidays
• Support for Community Involvement
• Bonus Plans

WACKER, as an innovative chemical company, makes a vital contribution toward improving the quality of life around the world by developing intelligent solutions for sustainable growth. Our culture focuses on building and retaining diverse and inclusive teams. WACKER offers a great work environment, professional development, challenging careers, competitive benefit offerings and beyond through giving back to our communities.

Be part of our WACKER family, across all nations!

We are looking forward to your online application at www.wacker.com.
Reference Code: 23183 

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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.