Regulatory Affairs and Quality Manager

4 weeks ago

St Paul, United States Heraeus Full time

Regulatory Affairs and Quality ManagerIncubator New BusinessesLocation REMOTEPermanent Full TimeAbout HeraeusSolutions from the Heraeus Group provide faster internet, rid water of germs, and keep hearts beating in time. As a broadly diversified and globally leading family-owned technology company, we combine materials expertise and technological leadership to create the most diverse products, all with one thing in common: World-class quality. Working with customers around the world, we shape the future and provide vital innovations in the areas of Metals & Recycling, Healthcare, Semiconductor & Electronics and Industrials. Heraeus is one of the top 10 family-owned companies in Germany and has a team of around 17,200 employees in 40 countries.About Engineered Tissue SolutionsEngineered Tissue Solutions was acquired in 2021 by the Heraeus Group, a FORTUNE Global 500 listed and broadly diversified family-owned technology company. Learn more about Heraeus Group at www.heraeus.com.The following challenges await you:•Lead and own regulatory and quality functions to ensure compliance with applicable laws and regulations in development, manufacturing (via CMOs), and marketing of ETS products.•Develop and manage regulatory and quality procedures required to manage post market surveillance, product complaints, clinical feedback and evaluations, and field actions. •Ensure regulatory requirements are met and risk management considerations are addressed in the design control process and specific product development plans.•Coach and mentor the development and commercial team on regulatory and design control activities.•With support of external regulatory SME's, provide regulatory guidance and strategy for new product development, product marketing and promotion, and interactions with the FDA or other regulatory bodies.•Create US regulatory submissions for 510k clearance and pre-market authorizations, with external SME or consultant support as needed.•Own and improve the quality management system, procedures, and training to enable efficient and compliant company operations. •Acts as the company Management Representative•Responsible for internal and external audits (FDA, notified bodies, suppliers, etc); ensure compliance with relevant FDA and ISO 13485 requirements. Your Profile:•10+ years experience in the medical device field in quality or regulatory roles with direct experience as described in the job requirements.•Bachelor's or advanced degree in engineering or related science, materials research, or related field.•Strong understanding and experience with regulatory and quality requirements for product development, manufacturing, and marketing products under ISO 13485 and 21 CFR 820, GMP and FDA 510k and PMA pathways.•Hands-on and versatile mindset required to succeed in a small company or start-up environment.•Effective and efficient in a remote or hybrid work environment and working with associates across the US and Europe.•Competent and efficient technical writing skills. •Demonstrate discretion, confidentiality, and professionalism when representing the company.•ASQ certification and Regulatory Affairs Professional Society (RAPS) medical device certification preferred.•Experience in a small company or start-up environment. Diversity is at the core of our Vision, Mission, and Values. Heraeus is committed to an inclusive workforce that fully represents many different cultures, backgrounds and viewpoints. We can provide you with the opportunity - and Open Space - where your ideas and career can grow and advance. A career with Heraeus offers attractive compensation, top-notch benefits, and an ideal environment that supports your professional development.In case of any questions, our HR team is available at hrdirect-americas@heraeus.com. You can also find more information at www.heraeus.com/careersusa.Keywords: wound care, regulatory, quality

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