Regulatory Affairs

Job not on LinkedIn

🔥 9 minutes ago

🏄 California – Remote

🏄 California – Remote

💵 $104.8k - $163.7k / year

⏰ Full Time

🟡 Mid-level

🟠 Senior

🚔 Compliance

🦅 H1B Visa Sponsor

This company has sponsored H1B visas in the past.

👻 Ghost score 0%

What it means: how likely this posting is sitting open without active hiring.How to read it: 60% or higher means we think this is a ghost. Lower scores are less of a worry.How we score it: age, reposts, open roles vs team size, how fast jobs close, and whether pay is listed.Fine print: an estimate from public data, not a judgment of the company. Real jobs can score high, so treat it as a hint, not a fact.

Apply Now

Find Similar Remote Jobs

Set Up Email Alert For New Jobs

📊 Check your resume score for this job

Improve your chances of getting an interview by checking your resume score before you apply.

Upload Resume

Agilent Technologies

WebsiteLinkedInAll Job Openings

10,000+ employees

Founded 1999

🍽️ Food & Beverage

🏥 Healthcare

💼 Consulting

💰 $500M Post-IPO Debt on 2019-09

Food & Beverage • Healthcare • Consulting

Agilent Technologies is a global leader in the field of analytical and laboratory instruments. The company offers a diverse range of products and solutions, including gas and liquid chromatography, mass spectrometry, lab supplies, and software and informatics. Agilent serves various industries, such as biopharma, food and beverage testing, clinical diagnostics, and environmental testing. Additionally, Agilent provides comprehensive services for lab management, maintenance, and instrument repair. They focus heavily on advancing science through sustainable solutions and supporting genomics, pathology, and cancer research with advanced technologies.

📋 Description

• Ensure global product compliance and adherence to applicable regulatory requirements • Support regulatory submissions for product marketing in international markets • Provide regulatory input throughout product development from design and development through commercialization • Monitor evolving global regulations and assess their impact on company operations • Maintain regulatory documentation and support post-market compliance • Prepare, coordinate, and submit regulatory documentation and product registrations for the U.S., EU, Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries • Compile, review, and maintain technical files, GSPRs, and CERs • Partner with R&D, Quality, and Commercial teams on product development, design control, labeling, and change control • Collaborate with Quality Systems on cGMP, GMP/QSR, ISO 13485, and MDSAP compliance • Perform product risk assessments and support complaint and non-conformance investigations • Manage recalls, MDR, advisory notices, and post-market regulatory reporting • Provide guidance on submission planning, global compliance strategies, risk classification, and literature research • Research and interpret global regulations and recommend compliance strategies • Manage product registration, listing, licensing, and business-license renewals • Develop regulatory SOPs, guidelines, templates, and training content; deliver compliance training • Review and approve labeling, IFUs, user manuals, SDSs, and promotional content • Monitor complaint-handling systems and support CAPA management • Track regulatory changes and perform gap analyses • Generate import/export documentation and facilitate customs clearance • Lead or support PMS activities, including complaint trend analysis, vigilance reporting, and PMS documentation under IVDR • Develop and execute PMPF plans and integrate performance data into CERs and risk management • Support internal and external audits and inspections; coordinate responses to findings • Assess regulatory impacts of product and process changes and support change control • Coordinate with external regulatory consultants or local agents and support regulatory project budgeting and planning • Support R&D from concept and feasibility through design, verification/validation, and commercialization • Provide ongoing regulatory support for marketed products, post-market modifications, and lifecycle management

🎯 Requirements

• Practical experience in the IVD field, with a solid understanding of regulatory requirements • Knowledge of compliance requirements related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other relevant markets • Familiarity with ISO 13485:2016, ISO 14971:2019, and MDSAP • Strong analytical and problem-solving skills • Effective interpersonal and cross-functional collaboration skills • Strong organizational skills, attention to detail, and ability to manage multiple priorities and deadlines with some guidance • Clear oral and written communication skills • Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS • Bachelor’s degree or equivalent experience • Minimum of three years of experience in the regulated medical device, IVD, or a related industry • Strong knowledge of international submissions across LATAM, the EU, Asia, and MDSAP countries • Experience with antibody-based diagnostics is strongly preferred • Excellent leadership, communication, and project management skills • Familiarity with MasterControl, Veeva Vault, or AssurX is highly desirable • Primarily local travel during the business day, with some out-of-area and overnight travel expected • Ability to work in the United States, based on the posting location

🏖️ Benefits

• Eligibility for bonus • Stock • Benefits • Option to work remotely • Less than 20% travel required