Sr. RA Specialist

Sr. RA Specialist Noah Medical - 2.0 San Jose, CA Job Details $109,000 - $136,000 a year 9 hours ago Benefits Paid parental leave Health savings account Paid holidays Disability insurance Health insurance Dental insurance Flexible spending account Parental leave Vision insurance Life insurance Pet insurance Qualifications Quality control corrective actions FDA submissions Regulatory inspections Investigations regulatory compliance Technical documentation ISO standards 5 years Preventive action implementation Engineering Bachelor's degree in biomedical engineering Compliance audits & assessments Filing Biomedical Engineering Corrective and preventive actions (CAPA) Internal investigations Regulatory legal research Collaboration with product development teams Analysis skills Project management Bachelor's degree in engineering Product development Industry trends Compliance documentation Quality compliance management Organizational skills Internal compliance assessments Collaboration with manufacturing teams Regulatory submission editing and review Design controls Biomedical regulatory compliance Full Job Description Who We Are Noah Medical is building the future of medical robotics. Our next generation robotic platform targets early diagnosis and treatment of patients across multiple indications. We are looking for exceptional engineers and key team members. Our incredibly talented team of engineers, innovators, and industry leaders bring years of experience from the top healthcare companies in the world, including: Intuitive, Auris, Stryker, Johnson & Johnson, Boston Scientific, Verb Surgical, Mako, Think Surgical, Medrobotics, and Hansen. We are looking for talented, motivated and ambitious team members to revolutionize robotic surgery. About The Team Join our Quality team at Noah Medical, where you'll play a pivotal role in driving innovation and product leadership in medical robotics. We're a hands-on, technical, and solution-oriented, and accountable team, seeking like-minded individuals to join us. Utilizing a data-driven approach, we tackle challenges and fuel innovation. Committed to exceeding FDA and international regulatory standards, we take initiative, optimize processes, and implement agile quality management systems to foster continuous improvement. Our ultimate goal is to make a meaningful impact on patients' lives by setting new benchmarks and breaking barriers in the field of medical robotics. Come join us as we shape the future together! A Day In The Life Of Our Sr. RA Specialist Regulatory Strategy & Product Development Support development and execution of global regulatory strategies for new and existing medical devices. Provide regulatory guidance to cross-functional teams throughout product development, design changes, and sustaining engineering activities. Assess regulatory impact of product, process, labeling, software, and manufacturing changes. Participate in design reviews and product development activities to ensure regulatory requirements are incorporated. Regulatory Submissions & Registrations Prepare and submit regulatory submissions including FDA 510(k)s, international registrations, technical documentation, and other regulatory filings as required. Support compilation and maintenance of Design and Development Files (DDF), Technical Documentation, and regulatory submission dossiers. Coordinate submission activities with regulatory agencies, notified bodies, and international regulatory authorities. Track submission status and ensure timely responses to regulatory inquiries. Regulatory Compliance Monitor and interpret evolving regulatory requirements and standards, including

FDA, EU MDR, ISO

13485, MDSAP, and other applicable regulations. Ensure ongoing compliance with global regulatory requirements throughout the product lifecycle. Support implementation of new regulatory requirements within the Quality Management System (QMS). Maintain product registrations, licenses, and regulatory approvals. Labeling & Promotional Review Review product labeling, Instructions for Use (IFUs), marketing materials, and promotional content for regulatory compliance. Ensure claims are adequately supported and consistent with approved regulatory submissions. Audits & Inspections Support internal audits, external audits, notified body assessments, and regulatory inspections. Provide regulatory subject matter expertise during audits and inspections. Assist in developing responses to audit findings and regulatory observations. Cross-Functional Collaboration Collaborate with Quality, Product Development, and Manufacturing teams to support regulatory objectives. Support complaint investigations, CAPAs, post-market surveillance, and field actions from a regulatory perspective. Participate in management reviews and regulatory compliance reporting activities. Regulatory Intelligence Monitor industry trends, regulatory changes, guidance documents, and standards updates. Communicate regulatory changes and assess business impact. Recommend actions to maintain compliance and support business objectives. About You Bachelor's degree in Engineering, Life Sciences, Biomedical Engineering, Regulatory Affairs, or a related technical discipline. Advanced degree preferred. 5+ years of Regulatory Affairs experience within the medical device industry. Experience preparing and supporting FDA 510(k) submissions. Experience supporting international registrations and regulatory submissions preferred. Working knowledge of medical device development processes and design controls. Experience with Class II and/or Class III medical devices preferred Strong knowledge of:

FDA 21 CFR

Part 820 and applicable FDA regulations, EU MDR (2017/745), ISO 13485, ISO 14971 Risk Management, MDSAP requirements, Medical device labeling requirements Regulatory Affairs Certification (RAC) preferred. Experience with software-enabled medical devices and cybersecurity submissions preferred. Experience supporting global markets including EU, Canada, Australia, and Asia-Pacific regions. Experience interacting directly with FDA, notified bodies, and international regulatory agencies Strong project management and organizational skills. Excellent written and verbal communication skills. Strong analytical and problem-solving abilities. Ability to work independently with minimal supervision. Proficiency with Microsoft Office and electronic Quality Management Systems (eQMS) #LI-Hybrid Benefits & Perks (For Full Time Employees): Competitive Salary Comprehensive health insurance including Medical, Dental and Vision + HSA and FSA options Equity & Bonus Program Life Insurance (company paid & supplemental) and Disability insurance Mental health support through medical insurance programs Legal and Pet Insurance 12+ paid holidays, Flexible Time Off + Sick Time Paid parental leave In-office snacks and beverages In-office lunch stipend

Learning & Development Opportunities:

On-demand online training and book reimbursement Team building and company organized social and celebration events Noah Medical may offer remote, hybrid, or onsite work arrangements within the state of California depending on the specific team and/or role where applicable. Noah Medical is an Equal Opportunity Employer. We celebrate diversity and are committed to ensuring an inclusive environment for our employees. Applicants are considered for all positions without regard to race, color, religion, sex or gender, gender identity or expression, sexual orientation, national origin, ancestry, age, genetic information, physical or mental disability, marital or protected military or veteran status, or any other consideration made unlawful by federal, state or local laws. Please visit our Careers Page to view our latest openings.

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