Please Contact: To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Dhanashree Teli at email address can be reached on # .
We have Contract role Regulatory Specialist Sr for our client at Santa Clara, CA. Please let me know if you or any of your friends would be interested in this position.
Position Details:
Regulatory Specialist Sr- Santa Clara, CA
Location : Santa Clara, CA 95054
Project Duration : 12 Months of contract
Pay Rate : $52.00 per hour on W2
Job Description:
We are seeking a highly driven and strategic Senior Regulatory Affairs Specialist to lead regulatory operations with a strong focus on global tender and regulatory affairs letters coordination and execution. This role is critical in ensuring timely, compliant, and high-quality regulatory deliverables to support international tenders, regulatory letters, and post-approval regulatory activities across multiple franchises. The ideal candidate operates with a high degree of independence, demonstrates strong cross-functional leadership, and can manage complex, multi-stakeholder deliverables with minimal oversight.
Key Responsibilities:
Tender Coordination & Execution
- Lead and own end-to-end global tender regulatory deliverables, including regulatory documentation, certifications, and product compliance data
- Serve as the central point of accountability for tender-related regulatory activities across franchises
- Drive alignment and coordinate inputs across SMEs, including international affiliates, manufacturing, quality, packaging, R&D, and labeling teams
- Develop and manage tender trackers, timelines, and governance structures to ensure visibility and on-time execution
- Identify risks, proactively escalate issues, and implement mitigation strategies to ensure tender success and timeliness
- Ensure compliance with regional and country-specific regulatory requirements
- Develop and monitor KPIs and dashboards to track performance and drive continuous improvement
Regulatory Operations & Documentation
- Lead the review, coordination, and tracking of regulatory letters (LoA, PoA, controlled substance letters, evidence of conformance, etc)
- Executes preparation and submission of Certificates to Foreign Governments (CFGs), CFG-NE, COEs in the FDA database
- Provide oversight and quality review of Declarations of Conformity (DoC), DoC templates, and translations, ensuring compliance with MDR and global standards and regulations
- Support translation requests through the translation s portal
- Review EU MDR DoC translations for accuracy and consistency
- Ensure adherence to Good Documentation Practices (GDP) across all deliverables
- Executes and tracks addendum labeling requests
Cross-Functional Leadership
- Act as a key liaison between Regulatory Affairs, Quality, Supply Chain, Legal, and international affiliates to resolve complex regulatory challenges
- Facilitate cross-functional governance meetings and drive decision-making and accountability
- Influence stakeholders and align priorities across multiple functions and geographies
Process Improvement & Governance
- Identify and implement process improvements and automation opportunities within regulatory operations and tender workflows
- Lead and support change management activities, including updates to procedures, templates, and systems
- Maintain and enhance trackers, SharePoint repositories, and documentation systems to improve efficiency
Compliance & Issue Management
- Identify and address compliance risks and quality system gaps
- Support CAPA investigations and remediation activities
- Troubleshoot and resolve regulatory operational challenges impacting deliverables
Top three skills for the role:
- Global Tender & Project Management: Leads end-to-end regulatory support for international tenders with full accountability for timelines and deliverables
- Cross-Functional Leadership: Drives alignment and execution across multiple stakeholders, influencing without direct authority
- Regulatory Operations Expertise (Global): Deep knowledge of regulatory documentation, processes, and international requirements (e.g., MDR, global submissions)
Qualifications & Skills:
- Proven experience in Regulatory Affairs, Regulatory Operations, or international submissions
Strong experience managing complex, cross- functional initiatives independently - Demonstrated expertise in global regulatory requirements (e.g., EU MDR, international markets)
- Advanced project management, prioritization, and organizational skills
- Excellent stakeholder management and influencing skills, including the ability to drive alignment without direct authority
- Strong critical thinking and problem-solving capabilities
- Ability to operate with minimal oversight and high accountability for outcomes
To discuss this amazing opportunity, reach out to our Talent Acquisition Specialist Diresh Krishnan at email address can be reached on # .
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