Regulatory Affairs Specialist

Regulatory Affairs Specialist

The Regulatory Affairs Specialist will be responsible for ensuring global product compliance and adherence to applicable regulatory requirements. This role supports regulatory submissions for product marketing in international markets and contributes to maintaining compliance across the company's IVD portfolio.

The position supports new product development by providing regulatory input and guidance throughout the product lifecycle from design and development through commercialization to ensure compliance and timely market access.

Responsibilities also include monitoring evolving global regulations, assessing their impact on company operations, and supporting updates to processes and documentation as needed.

Additional activities include maintaining regulatory documentation, assisting with post-market compliance, and contributing to internal training and continuous improvement initiatives within the Regulatory Affairs function.

Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the U.S. (FDA), EU (IVDR), Canada, LATAM, Asia-Pacific, Middle East, and MDSAP-participating countries, ensuring timely approvals and continued market access.

Compile, review, and maintain regulatory technical documentation, including technical files, GSPRs, and CERs, to ensure compliance with IVDR and country-specific requirements.

Partner with R&D, Quality, and Commercial teams to integrate regulatory requirements into product development, design control, labeling, and change control processes.

Ensure company-wide compliance with cGMP and established procedures by collaborating with Quality Systems on adherence to GMP/QSR, ISO 13485, and MDSAP standards.

Perform product risk assessments and support evaluation of complaints and non-conformances; assist with investigation and documentation.

Manage and support recalls, Medical Device Reporting (MDR), advisory notices, and related post-market regulatory reporting.

Provide strategic regulatory guidance on submission planning, global compliance strategies, risk classification, and literature research.

Research and interpret global regulations to assess impact and recommend actionable compliance strategies.

Manage product registration, listing, and licensing activities, including renewal of business licenses in global markets.

Develop and maintain regulatory SOPs, guidelines, templates, and training content; deliver Regulatory Affairs and company-wide regulatory compliance training.

Review and approve product labeling, IFUs, user manuals, SDSs, and promotional content for regulatory compliance.

Monitor complaint-handling systems and support CAPA management to ensure effective resolution and prevention of recurrence.

Track changes in global regulatory requirements and perform gap analyses to ensure continued compliance and proactive remediation.

Generate and manage import/export documentation and facilitate customs clearance for product distribution.

Lead or support global Post-Market Surveillance (PMS) activities, including complaint trend analysis, vigilance reporting, and preparation of PMS documentation in accordance with IVDR.

Develop and execute Post-Market Performance Follow-up (PMPF) plans to gather performance data, literature, and user feedback for integration into CERs and risk management.

Contribute to departmental continuous improvement initiatives to enhance process efficiency, regulatory compliance, and documentation quality.

Support internal and external audits and inspections by regulatory authorities and notified bodies; prepare documentation and coordinate responses to audit findings.

Assess the regulatory impact of product and process changes and contribute to the change control process to ensure timely and compliant implementation.

Coordinate with external regulatory consultants or local agents for international submissions; support budgeting and planning activities for regulatory projects.

Support R&D throughout the product development process, from concept and feasibility through design, verification/validation, and commercialization, to ensure regulatory requirements are met at every stage.

Provide ongoing regulatory support for marketed products, including evaluation of design or process changes, post-market modifications, and lifecycle management activities to maintain global compliance.

Core Competencies

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 international standards and regulations applicable to IVD devices, including ISO 13485:2016, ISO 14971:2019, and MDSAP.

Strong analytical and problem-solving skills, with the ability to investigate and resolve regulatory issues.

Effective interpersonal skills and the ability to collaborate within cross-functional teams.

Strong organizational skills, attention to detail, and ability to manage multiple priorities and meet deadlines with some guidance.

Clear oral and written communication skills appropriate for internal and external stakeholders.

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

Qualifications

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 eQMS platforms, including MasterControl, Veeva Vault, or AssurX, is highly desirable.

Primarily local travel during the business day, with some out-of-area and overnight travel expected. Less than 20% travel is required.

Additional Details

This job has a full time weekly schedule. It includes the option to work remotely. Applications for this job will be accepted until at least October 5, 2026 or until the job is no longer posted. The full-time equivalent pay range for this position is $97,920.00 - $183,600.00/yr plus eligibility for bonus, stock and benefits. Our pay ranges are determined by role, level, and location. Within the range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. During the hiring process, a recruiter can share more about the specific pay range for a preferred location. Pay and benefit information by country are available at: Technologies, Inc. is an Equal Employment Opportunity and merit-based employer that values individuals of all backgrounds at all levels. All individuals, regardless of personal characteristics, are encouraged to apply. All qualified applicants will receive consideration for employment without regard to sex, pregnancy, race, religion or religious creed, color, gender, gender identity, gender expression, national origin, ancestry, physical or mental disability, medical condition, genetic information, marital status, registered domestic partner status, age, sexual orientation, military or veteran status, protected veteran status, or any other basis protected by federal, state, local law, ordinance, or regulation and will not be discriminated against on these bases. Agilent Technologies, Inc., is committed to creating and maintaining an inclusive in the workplace where everyone is welcome, and strives to support candidates with disabilities. If you have a disability and need assistance with any part of the application or interview process or have questions about workplace accessibility, please email View email address on click.appcast.io or contact View phone number on click.appcast.io. For more information about equal employment opportunity protections, please visit

Travel Required: Occasional

Shift: Day

Duration: No End Date

Job Function: Quality/Regulatory