Ada
Senior Regulatory Affairs and Quality Manager - US (f/m/x)
Remote (USA)
Full time
ABOUT US
At Ada, we envision a world where everyone has access to the healthcare they need. In one of the biggest challenges facing the world, we pioneered a new form of artificial intelligence, combining medical knowledge with bespoke reasoning technology, to empower millions of people to better understand their health, while working with, and supporting, medical doctors. We have global ambitions and are creating new possibilities for the future of health. And this is just the beginning. To date we’ve grown a diversely skilled team from over 55 countries and we’re growing rapidly.
At Ada, we envision a world where everyone has access to the healthcare they need. In one of the biggest challenges facing the world, we pioneered a new form of artificial intelligence, combining medical knowledge with bespoke reasoning technology, to empower millions of people to better understand their health, while working with, and supporting, medical doctors. We have global ambitions and are creating new possibilities for the future of health. And this is just the beginning. To date we’ve grown a diversely skilled team from over 55 countries and we’re growing rapidly.
ABOUT THE ROLE
You will report directly to the Vice president of Global regulatory Affairs and will be responsible for the operational activities of Regulatory compliance department
WHAT YOU WILL DO:
- Lead activities for maintenance, monitoring, and continuous improvement of the QM system
- Provide technical writing support to SOP owners and relevant stakeholders to ensure the quality of written processes.
- Ensure compliance to international regulations and standards through internal and external audits.
- Prepare audit plans, conduct audit meetings, coordinate audit process with process owners, perform internal audits, document audit evidence, and write audit reports.
- Lead CAPA Board, drive CAPA processes (Corrective actions and preventive actions), and facilitate discussions between relevant stakeholders to determine root cause of non-conformance and support all relevant CAPA steps
- Drive the development, establishment, and management of a comprehensive QMS under GCP, GLP and GMP requirements
- Develop and drive product submission (510K and/or PMA) strategy
- Manage vendor/supplier audits (remote and/or onsite)
- Qualifying new suppliers and maintaining a Qualified Supplier Base
- Ensuring the process-compliant purchasing process by maintaining the quality-relevant data
- Establishing and revising the current quality processes in cooperation with relevant stakeholders
- Coordinating quality issues as a link between service provider, procurement and project management
- Supporting quality-relevant topics in supplier negotiations
- Reviewing nonconformance records (internal/external) to determine disposition, root cause and need for corrective and preventive
- Potentially develop and lead a team across US
- Provide training sessions to relevant parties
WHAT YOU WILL BRING :
- Minimum of a master degree in a technical or related field
- Previous QA experience (5-6 years) that provides the knowledge, skills, and abilities to perform the job or an equivalent combination of education, training, and experience
- Minimum of 7 years quality assurance & regulatory affairs experience specifically within the medical device industry
- Experience leading FDA inspections and FDA communications
- Experience working with Notified Bodies and leading Notified Body audits
- Expert knowledge and interpretation of 21 CFR Part 820, 21 CFR Part 210/211, EU MDR, ISO 13485, MDSAP, etc
- Experience in either 510(k) or PMA Submissions
- Auditor certification
- Strong interpersonal, organisational, problem-solving and analytical skills; strong attention to detail
- Strong working knowledge of quality management systems and tools
- Equivalent experience in a regulated industry
WHAT'S AWAITING YOU AT ADA:
- Join our global health mission to improve the health of billions of people around the world
- Work in an international environment (55+ nationalities) and with medical doctors & experts
- Work with cross-functional & diverse teams of smart, purpose-driven peers
- Work wherever you feel most comfortable – home, office, or a bit of both
- Receive financial support to help set up your home office space
- Enjoy your country-specific vacation days to unplug, rest and recharge
- Maintain a healthy work-life balance with our flexible working hours and locations
- Keep fit with discounted Urban Sports Club or Class Pass memberships
- Meditate your stress away with a free Headspace subscription
- Learn German with our virtual German classes
- Meet and collaborate with colleagues via community days, virtual coffee chats, company parties, team celebrations
How to apply
Apply via the link below.
Ada
Hi, we’re Ada. We’ve been working hard to improve health outcomes since 2016. Built by doctors and scientists and powered by a 10 million-strong userbase, our medical AI simplifies healthcare journeys and helps people take care of themselves.
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