RA Associate - xUDID and Variations SupportReq # JR - 019915 Location Bengaluru, Karnataka, India Additional Locations 56 Job Category Regulatory Affairs Date posted 07/30/2020
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Baxter provides a broad portfolio of essential renal and hospital products, including home, acute and in-centre dialysis; sterile IV solutions; infusion systems and devices; parenteral nutrition; surgery products and anesthetics; and pharmacy automation, software and services. The company’s global footprint and the critical nature of its products and services play a key role in expanding access to healthcare in emerging and developed countries. Baxter’s employees worldwide are building upon the company’s rich heritage of medical breakthroughs to advance the next generation of healthcare innovations that enable patient care.
Position Title: Regulatory Affairs Associate – xUDID & Variations Support
This role is responsible for providing regulatory support for on-market products. Supports Global Regulatory Strategy as it pertains to global Unique Device Identification Data (xUDID) to support the global registration and ongoing compliance of medical device product(s) throughout the product life cycle.
Provides support for global regulatory processes and systems for submission of xUDID to ensure that Baxter’s complies with both local and global requirements and the requirements.
Support change assessment, variation planning, creation of submission documentation, identification of local submission requirements, product/facility change management, process support, and participation in project sub-teams.
Establishes appropriate cross-functional partnerships within RA and other functions to coordinate the collection, review, validation, and maintenance of all required xUDID such as:
- Responsible for coordinating the collection, review, validation, and maintenance of all required xUDID from appropriate sources within the design team and routing product data for approval to ensure required compliance and adherence to regulatory deadlines.
- Identify the stakeholders and conduct regular meetings to ensure compliance with on-going xUDID submissions and regulatory deadlines.
- Provides clear communication of purpose, requirements, and expectations of the design team.
- Routes data source and xUDID to all Subject Matter Experts (SMEs) for review and validation prior to submission.
- Responsible for coordinating issue resolution when discrepancies or questions related to product data might arise.
- Performs xUDID document formatting and data transformation necessary for transmission to a target MOH database.
- Routes data for approval in Product Life-cycle Management (PLM) system.
- Helps perform xUDID document transmission (system) testing when necessary.
- Effectively performs gap analysis and proposes solutions including develop and document sound regulatory decisions and justifications.
- Update and close xUDID task in change control (when appropriate).
- Review and provide regulatory impact assessments for changes and Support global submission deliverables for product variation submissions
- Execute global plans and regulatory submission deliverables for sustaining variations
- Support implementation, testing, and lifecycle management of PLM (including validation).
Understanding of global regulatory knowledge and expertise in xUDID and device labeling requirements and implementation will be an advantage. Ability to manage complex projects and timelines in a matrix team environment. Strong project management and organizational skills. Strong oral and written communication and presentation skills Full professional proficiency in the English language. Demonstrated interpersonal skills including strong negotiation and facilitation skills Ability to independently identify compliance risks and escalate when necessary Bachelor’s degree or country equivalent in related scientific discipline with a minimum of 4 years of regulatory experience in RA or related field, including managing people or projects.
Baxter is committed to working with and providing reasonable accommodations to individuals with disabilities. If, because of a medical condition or disability, you need a reasonable accommodation for any part of the application or interview process, please send an e-mail to Americas_TTA@baxter.com and let us know the nature of your request along with your contact information.