Regulatory Affairs and Quality Manager (Remote)
Heraeus
- Rolla, MO
- Permanent
- Full-time
- 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.
- 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.