SR. REGULATORY AFFAIRS SPECIALIST Job at Direct Staffing Inc, Santa Clara, CA

bGQzTmZWR3BzOGJLZEV1V0RTTTg1cVdrMVE9PQ==
  • Direct Staffing Inc
  • Santa Clara, CA

Job Description

We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team. Reporting to the Sr. Director, Regulatory Affairs (CDx), the successful candidate must have global regulatory experience working in IVD, Medical Devices or Pharmaceutical, with a history of successful regulatory submissions, registrations, 510(k)’s and PMA approvals in US and Asia. The preferred candidate has experience in Companion Diagnostics, and has lead company-sponsored interactions with regulatory bodies, especially FDA. The candidate must have excellent oral and written communication skills. The candidate will represent Regulatory Affairs on project teams and in close collaboration with pharmaceutical partners. Responsibilities

  1. Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic products in global markets.
  2. With Regulatory Sr. Management, develops regulatory strategies related to CDx product development.
  3. Provides regulatory assessments and plans for international product registrations and approvals.
  4. Interacts and collaborates with pharmaceutical partners in joint meetings.
  5. Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts.
  6. Works across the organization to ensure alignment of regulatory processes, standards and compliance. Provide expertise and advice in obtaining CDx product registrations and approvals in the Pacific Asian market.
  7. Represents the Company in 3rd party meetings, especially the FDA, and regulatory associations.
  8. Stays abreast of global IVD regulations and guidances, especially those relevant to Companion Diagnostics.
Bachelors or Masters Degree or University Degree or equivalent. Typically 8+ years relevant experience for entry to this level. Post-graduate and/or certification/ license may be required. Requires specialized depth and/or breadth of expertise in job. Not a natural progression from Advanced level. Additional Information All your information will be kept confidential according to EEO guidelines. Direct Staffing Inc #J-18808-Ljbffr Direct Staffing Inc

Job Tags

Similar Jobs

Perkins and Will

Lab Planner Job at Perkins and Will

 ...Planner will be responsible for assisting the laboratory project planning effort toward the successful completion of complex technology...  ...computational research, and higher education science teaching spaces ~ Bachelors degree in Architecture required ~ Masters degree... 

ASK Consulting

Field Engineer (272791) Job at ASK Consulting

 ...accordingly within About ASK: ASK Consulting is an award-winning technology and professional services recruiting firm servicing Fortune 500 organizations nationally. With 5 nationwide offices, two global delivery centers, and employees in 42 states-ASK Consulting... 

Remote VA

Photo Editor Job at Remote VA

 ...Photo Editor Location: Remote work We are seeking a skilled and meticulous Photo Editor to join our creative team. The ideal candidate will possess strong technical skills in color correction, retouching, background removal, image resizing, and optimization, as... 

Coinbase

Data Scientist II Job at Coinbase

 ...are held multiple times annually to foster collaboration, connection, and alignment. Attendance is expected and fully supported.Data Science is an integral component of Coinbases product and decision making process: we work in partnership with Product, Engineering and... 

Volunteers of America National Services

MDS Coordinator Job at Volunteers of America National Services

 ...Come join our awesome team as a MDS Coordinator, at Rochester Rehab & Living Center. You would be part of a team that is proudly listed among the Best Nursing Homes by U.S. News & World Report! Rochester Rehab & Living Center is part of Volunteers of America National...