DUTIES AND RESPONSIBILITES:
• Responsible for elicitation, analysis, and documentation of business requirements.
• Research and exploration of user requirements, costs, and benefits in support of documentation required for the demand management process.
• Responsible for analyzing the business needs to identify new processes and process improvements that will meet those needs.
• Documents current business processes and models to define requirements and/or gaps.
• Analyze detailed system factors including input/output requirements, information and paper flow, hardware, and software needs.
• Analyze “soft" system factors including roles, responsibilities, policy, culture, etc.
• Evaluate the impact of potential software and process changes on the organization.
• Develop and facilitate groups as necessary in pursuit of eliciting and defining requirements.
• Assist in the creation of the business case documentation.
• Understanding of architectural consistency and usability standards.
• Defines and develops user test cases and validates test results during testing.
• Executes unit and functional test cases.
• May conduct system demonstrations and training sessions, as well as participate in design/review of training content.
• Plays a third level support role by helping to troubleshoot and resolve issues with production systems.
• Participates in associate meetings and communicates any concerns to management.
QUALIFICATIONS AND REQUIREMENTS:
• Bachelor’s degree in computer science, Information Systems, Business, or another related field or equivalent work experience.
• Proven experience leading data migration requirements from legacy systems into a new ERP (Sage X3) environment
• Strong hands-on expertise in requirements elicitation, documentation, and management, with emphasis on data mapping, transformation rules, and validation
• Deep understanding of data structures, data quality, and migration best practices, with the ability to identify gaps and risks early
• Self-driven and accountable professional with strong stakeholder management and communication skills, able to drive outcomes with minimal oversight
• Working knowledge of Confluence and JIRA.
• Experience in any of the following business areas is desired: Sales operations, order entry, accounting, finance, procurement, warehouse operations, order management, and order fulfillment.
• Minimum of 3-5 years’ business analysis or systems analysis experience is preferred.
• Bonus: Sage X3 experience (ERP).
Associate is expected to operate at a proficient level across the following areas of technical knowledge and skill:
• Ability to organize and prioritize work.
• Detail oriented, proactive, creative, and efficient
• Intermediate level abilities in Excel, Outlook, PowerPoint, Visio, and Word
• Familiarity with application integration methods to include understanding of data mapping process.
• Ability to effectively work both independently and collaboratively in a team environment
• Ability to work on simultaneous and complex projects, with domain expertise in at least one business area.
• Expertise in ERP solution selection and implementation is a plus
• Ability to communicate effectively to both technical and non-technical audiences in written and non-written format
• Ability to work with all levels of associates
• Ability to work with minimal supervision in a very dynamic environment
• Ability to learn new systems and tools
• Knowledge of software development life cycle methodologies, processes, and procedures.
• Active listener
• Effective in a variety of formal/informal presentation settings: one-on-one, small, and large groups.
Job Title: Senior Regulatory Affairs Specialist
Location: Pacheco, CA
Duration: 12 – 18 Months
Position Summary
We are seeking an experienced and detail-oriented Senior Regulatory Affairs Specialist to support global regulatory compliance and market access activities for our In Vitro Diagnostics (IVD) product portfolio. This role is responsible for managing international regulatory submissions, maintaining product registrations, supporting product development initiatives, and ensuring continued compliance with global regulatory requirements.
The ideal candidate will have a strong background in IVD regulations, international market registrations, and post-market compliance activities. This position works closely with cross-functional teams including R&D, Quality, Manufacturing, Operations, and Commercial teams to ensure regulatory requirements are integrated throughout the product lifecycle.
Key Responsibilities
Regulatory Strategy & Submissions
- Prepare, coordinate, and submit regulatory documentation and product registrations for key global markets, including the United States, European Union, Canada, Latin America, Asia-Pacific, Middle East, and MDSAP-participating countries.
- Manage product registrations, listings, licenses, renewals, and regulatory approvals to maintain uninterrupted market access.
- Provide regulatory strategy and guidance for new product introductions and lifecycle management activities.
- Coordinate activities with international consultants, distributors, and in-country regulatory representatives.
Product Development Support
- Partner with R&D and Quality teams throughout the product development lifecycle, from concept through commercialization.
- Provide regulatory input regarding design controls, risk management, verification and validation activities, labeling, and change control.
- Assess regulatory impact of product and process changes and support implementation activities.
Regulatory Compliance
- Maintain technical documentation including Technical Files, General Safety and Performance Requirements (GSPR), Clinical Evaluation Reports (CER), risk management files, and supporting regulatory records.
- Ensure compliance with applicable regulations and standards, including IVDR, FDA requirements, ISO 13485, ISO 14971, and MDSAP.
- Monitor changes in global regulations and perform regulatory impact assessments and gap analyses.
Post-Market Surveillance & Vigilance
- Support complaint investigations, adverse event reporting, recalls, advisory notices, and Medical Device Reporting (MDR).
- Lead or support Post-Market Surveillance (PMS) activities, including trend analysis, vigilance reporting, and documentation updates.
- Develop and execute Post-Market Performance Follow-up (PMPF) activities and contribute data to Clinical Evaluation Reports and risk management documentation.
- Support CAPA investigations and implementation of corrective actions.
Quality Systems & Audits
- Collaborate with Quality Systems to ensure compliance with GMP/QSR, ISO 13485, and MDSAP requirements.
- Support internal audits, external audits, inspections, and notified body assessments.
- Prepare documentation and responses to regulatory agency and auditor inquiries.
Training & Continuous Improvement
- Develop regulatory procedures, templates, guidance documents, and training materials.
- Deliver regulatory compliance training to internal stakeholders.
- Participate in continuous improvement initiatives to strengthen regulatory processes and documentation quality.
Required Qualifications
- Bachelor's degree in Life Sciences, Regulatory Affairs, Biomedical Engineering, Chemistry, Biology, or related field.
- Minimum of 3 years of regulatory affairs experience within the medical device or IVD industry.
- Experience preparing and supporting international regulatory submissions and product registrations.
- Working knowledge of:
- EU IVDR 2017/746
- FDA regulations
- ISO 13485:2016
- ISO 14971:2019
- MDSAP requirements
- Global regulatory frameworks
Preferred Qualifications
- Experience with international submissions in Europe, Latin America, Asia-Pacific, and MDSAP markets.
- Experience with antibody-based diagnostic products.
- Regulatory Affairs Certification (RAC) preferred.
- Experience working with electronic Quality Management Systems (eQMS) such as MasterControl, AssurX, or Veeva Vault QMS.
