Regulatory Affairs

This is a fully remote position, open to applicants in California.

📋 Description

• Ensure global product compliance and adherence to relevant regulatory standards.

• Assist in regulatory submissions for product marketing across international markets.

• Provide regulatory guidance throughout the product development process from design to commercialization.

• Monitor changes in global regulations and evaluate their effects on company operations.

• Maintain regulatory documentation and support compliance activities post-market.

• Prepare, coordinate, and submit regulatory documents and product registrations for the U.S., EU, Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries.

• Compile, review, and keep technical files, GSPRs, and CERs up to date.

• Collaborate with R&D, Quality, and Commercial teams on product development, design control, labeling, and change control processes.

• Work together with Quality Systems to ensure compliance with cGMP, GMP/QSR, ISO 13485, and MDSAP standards.

• Conduct product risk assessments and assist in investigations of complaints and non-conformances.

• Manage recalls, MDR, advisory notices, and post-market regulatory reporting requirements.

• Offer guidance on submission planning, global compliance strategies, risk classification, and conduct literature research.

• Research and analyze global regulations to recommend compliance strategies.

• Oversee product registration, listing, licensing, and renewals of business licenses.

• Develop regulatory SOPs, guidelines, templates, and training materials; deliver compliance training sessions.

• Review and authorize labeling, IFUs, user manuals, SDSs, and promotional content.

• Monitor complaint-handling systems and assist in CAPA management.

• Track regulatory changes and conduct gap analyses.

• Generate import/export documentation and assist with customs clearance processes.

• Lead or support PMS activities, including complaint trend analysis, vigilance reporting, and PMS documentation under IVDR.

• Develop and implement PMPF plans and incorporate performance data into CERs and risk management activities.

• Support internal and external audits and inspections; coordinate responses to audit findings.

• Evaluate regulatory implications of product and process modifications and assist with change control procedures.

• Collaborate with external regulatory consultants or local agents and aid in budgeting and planning for regulatory projects.

• Support R&D from concept and feasibility through design, verification/validation, and commercialization phases.

• Provide ongoing regulatory support for marketed products, post-market modifications, and lifecycle management activities.

⛳️ Requirements

• Practical experience in the IVD field, with a strong grasp of regulatory requirements.

• Knowledge of compliance standards related to IVD Regulation (EU) 2017/746, NMPA, MFDS, AMDD, and other pertinent markets.

• Familiarity with ISO 13485:2016, ISO 14971:2019, and MDSAP standards.

• Strong analytical and problem-solving abilities.

• Effective interpersonal skills and capability for cross-functional collaboration.

• Excellent organizational skills, attention to detail, and proficiency in managing multiple priorities and deadlines with minimal guidance.

• Clear communication skills, both oral and written.

• Experience with eQMS platforms such as MasterControl, AssurX, or Veeva Vault QMS.

• Bachelor’s degree or equivalent experience.

• At least three years of experience in the regulated medical device, IVD, or a related sector.

• Strong understanding of international submissions across LATAM, the EU, Asia, and MDSAP countries.

• Experience with antibody-based diagnostics is highly preferred.

• Excellent leadership, communication, and project management skills.

• Familiarity with MasterControl, Veeva Vault, or AssurX is considered highly desirable.

• Primarily local travel during business hours, with occasional out-of-area and overnight travel expected.

• Ability to work in the United States, depending on the posting location.

🏝️ Benefits

• Eligibility for a bonus.

• Stock options.

• Comprehensive benefits package.

• Option to work remotely.

• Less than 20% travel required.