Senior regulatory affairs engineer

• Maintain and continue developing the following documentation systems in accordance with US, EU and Canadian medical device manufacturing legal requirements:
• b) Component-level engineering lifecycle documentation system (software, hardware)
• c) Process documentation system (production, servicing)
• Learn and understand technical aspects of the documents you are writing and ensure that documentation makes technical sense.
• Ensure that documentation system continues to serve as a proactive quality assurance tool, not a mindless bureaucratic burden.
• Successfully defend your work during regulatory audits.

Required qualifications

• Hands-on experience with ISO/IEC 13485, 14971, 60601, 62304, 62366, 81001
• Hands-on experience with 21 CFR 820, 21 CFR 1040, FDA guidance documents (dockets FDA-2021-D-0775, FDA-2022-D-0795, FDA–2008–D–0559) and at least 510k (PMA is a plus) pathway submissions and audits
• Hands-on experience with MDR 2017/745
• Bachelor’s (or higher) degree in one of the relevant engineering fields (computer science or electrical engineering) or practical proof of being self-taught in CS or EE.
• Obsessive attention to small details and quality
• Ability to work without use of AI
• Must be legally authorized to work in the United States

Work conditions

• Report to chief systems architect
• Work in Tarrytown headquarters (engineering department)
• Reasonable amount of remote work is possible
• Competitive compensation and benefits, including excellent health insurance
• Separate office room with a spectacular view
• Small team that welcomes and rewards initiative and treats each other like human beings
• Zero office politics