Regulatory Affairs Specialist 4 DGN Technologies San Jose California
Overview
Lead development of regulatory plans and provide regulatory guidance to product teams. Create regulatory submissions and maintain filings and licenses. Analyze design changes and assess impact on compliance. Drive improvements across product lifecycle.
What You'll Do9
- 1Develop regulatory plans and provide guidance to product teams
- 2Create comprehensive regulatory submissions
- 3Maintain all required filings and licenses
- 4Perform regulatory assessments for design changes
- 5Identify applicable standards and guidance documents
- 6Analyze impact of process changes on compliance
- 7Drive continuous improvement initiatives
- 8Own regulatory strategy for multiple product lines
- 9Collaborate with cross functional stakeholders
Requirements5
- 15+ years experience building regulatory frameworks
- 2AWS Certified professional
- 3CPC Card holder
- 45+ years building ETL pipelines with Spark and Airflow
- 53-5 seasons leading regulatory projects
Salary Insight
$125k per year
Location
Required Skills
Similar open positions
Explore active roles that match your skills and interests.
QPharma
VerifiedRegulatory and Compliance Specialist at QPharma Cedar Knolls NJ
We seek a Regulatory and Compliance Specialist to lead quality management systems and regulatory research at our Cedar Knolls New Jersey office. The ideal candidate will own SOP creation and training processes while driving improvements in compliance frameworks. This role offers opportunities to shape regulatory strategies within a pharmaceutical environment.
WHITE COLLAR TECHNOLOGIES INC
VerifiedRegulatory Affairs Associate Boston MA
Join White Collar Technologies Inc., a leading pharma consulting firm in Boston. This role involves client consulting across diverse projects requiring strong technical expertise. The position offers competitive compensation and comprehensive relocation support. Ideal candidates are detail-oriented professionals ready to contribute to high-impact initiatives.
DGN Technologies
VerifiedComponent Engineer 4 DGN Technologies San Jose CA
Lead component engineering efforts to support new product introduction initiatives. Own material readiness and manufacturability processes while collaborating with cross functional teams. Drive prototype development and supplier engagement to ensure timely product launches.
Actalent
VerifiedRegulatory Affairs Specialist Kansas City MO
The Regulatory Affairs Specialist leads QA and Regulatory Affairs to maintain and improve the Quality Management System for a medical device organization. This contract-to-hire role in Lenexa KS focuses on MDSAP certification and international regulatory compliance. The ideal candidate thrives in a collaborative environment and contributes to continuous improvement.
DGN Technologies
VerifiedUI/Human Factors Engineer 4 DGN Technologies San Jose California
Lead UI Human Factors Engineering efforts to understand user interactions and drive product improvements. Own end to end research and validation of intuitive products before launch. Shape user experience through iterative evaluation and formative analysis.
3202 St. Jude Medical Business Services, Inc.
VerifiedPrincipal Regulatory Affairs Specialist Vascular
Lead regulatory affairs specialist for Abbott Vascular on-site in St. Paul MN. Provide support for regulatory department ensuring efficient compliant business processes. Perform specialized level work assignments and analyze documentation for worldwide regulatory registration. Assist in identifying data needed and presenting it for product market entry.