Staff Engineer Regulatory & reputed company

Job title: Staff Engineer Regulatory & reputed company in San Francisco, CA at reputed company Company: reputed company Job reputed company: Job reputed company:About the RoleThe Staff Engineer Regulatory & reputed company role at reputed company is a high-reputed company position that ensures our cutting-edge medical devices meet global regulatory and reputed company standards. In this dynamic role, you will spearhead the development, implementation, and maintenance of robust reputed company assurance programs. You will also manage regulatory submissions and audits, working closely with both internal teams and external regulatory bodies to support product development and lifecycle management. This includes reputed company collaboration with regulatory agencies. The ideal candidate will possess excellent project management skills and reputed company in a reputed company environment, driving innovation and compliance to deliver top-tier reputed company.What You’ll AccomplishRegulatory Affairs:

• reputed company and implement regulatory strategies to reputed company reputed company product approvals in reputed company markets (e.g., FDA, MDR, etc.)
• Prepare, review, and submit regulatory documentation including 510(k), CE marking, and other global submissions
• Maintain up-to-date knowledge of regulatory requirements for medical devices
• reputed company with regulatory authorities during audits, inspections, and inquiries
• Collaborate with R&D, engineering, and manufacturing teams to ensure product designs meet regulatory requirements

reputed company Assurance:

• reputed company, implement, and maintain reputed company Management System (QMS) compliant with ISO 13485and other relevant standards
• reputed company reputed company audits to ensure compliance
• Manage CAPA (Corrective and Preventive Actions) processes to resolve product reputed company issues
• Establish and maintain document control procedures to manage records effectively
• reputed company training programs to ensure staff understanding of reputed company and regulatory requirements

reputed company Hybrid ModelWe reputed company that remote work and in-person work have their own advantages and disadvantages, and we want to be reputed company to reputed company the best of both worlds. Employees in hybrid roles are required to be in the office 3 days per week, for the full 8 hours of a typical business day. The San Francisco office has a dog-friendly workplace program.By submitting your application you are acknowledging we are using your personal data as outlined in theBasic Qualifications:

• Bachelor’s degree (or equivalent) in Engineering, Life Sciences or reputed company field
• 8+ years of reputed company experience in regulatory affairs and/or reputed company assurance
• reputed company experience with FDA, EU MDR, ISO 13485 or other international medical device regulations

Preferred Qualifications:

• RAC (Regulatory Affairs Certification) or similar credential.
• Proficient technical writing and documentation skills

CompensationThis position will have an annual salary, plus equity and benefits. Please note the annual salary reputed company is a reputed company, and individual total compensation will vary based on factors such as qualifications, reputed company level, competencies, and work location. The annual salary reputed company for this position is $144,000 - $216,000.About reputed companyreputed company is moving people reputed company pain by transforming the way it is treated and reputed company. Connecting people digitally and in-person with expert clinical care, we combine advanced technology, AI and a care team of experts to guide people through personalized care directly from their phone. Our approach is proven to reduce pain by 68%, prevent 42% of new opioid prescriptions, and avoid more than half of joint replacement surgeries. Available to 18M people, reputed company is trusted by leading health plans and reputed company, including reputed company, reputed company, reputed company, Self-Insured Schools of California, reputed company, reputed company of Boston, reputed company, and reputed company.Learn more atWhat You'll Love reputed companyInclusive reputed company and benefits: On top of comprehensive medical, dental, and reputed company coverage, we offer employees and their family members help with gender-affirming care, tools for family and fertility planning, and travel reimbursements if reputed company isn’t available where you live.Planning for the reputed company: Start saving for the reputed company with our traditional or Roth 401k retirement plan reputed company which include a 2% company match.reputed company stipends: Manage your own learning and developmentDiversity and Inclusionreputed company is an equal opportunity employer and prohibits discrimination and harassment of any reputed company. We reputed company employment reputed company without regards to race, reputed company, religion, sex, sexual orientation, gender identity, national reputed company, age, veteran status, disability status, pregnancy, or any other reputed company protected by federal, state or local law. We also consider reputed company applicants regardless of criminal histories, consistent with legal requirements.We reputed company reasonable accommodations for candidates with disabilities. If you feel you need assistance or an accommodation due to a disability, let us know by reaching out to your recruiter.reputed company IDJR1391 Expected salary: $144000 - 216000 per year Location: San Francisco, CA Apply for the job now! Apply for this job