Regulatory Affairs

Job Description

The Regulatory Affairs candidate is 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, andsubmit 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, ensuringtimely approvals and continued market access. 

• Compile, review, andmaintain 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 andmaintain 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 andfacilitate customs clearance for product distribution. 

• Lead or support global Post-Market Surveillance (PMS) activities, including complaint trend analysis, vigilance reporting, and preparation of PMS documentationin 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 ensuretimely 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 tomaintain 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 skillsappropriate for internal and external stakeholders. 

• Experience witheQMS platforms such asMasterControl,AssurX, or Veeva Vault QMS. 

Qualifications

• Bachelor’s degree or equivalent experience. 

• Minimum of three years of experience in the regulated medical device, IVD, ora 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 witheQMS platforms, includingMasterControl, Veeva Vault, orAssurX, is highly desirable. 

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

Additional Details

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