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

S3d6SmI2T1RtcEQ5Mi9wbnJ0a3RJVHZ0QVE9PQ==
  • 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

U.S. Navy

Naval Nuclear Propulsion Officer Candidate (NUPOC) Program - TX Job at U.S. Navy

 ...most elite and intellectually demanding communities in the U.S. Navy. While completing your degree, youll receive full pay and benefits...  ...Eligibility Requirements U.S. Citizen At least 19 years old and no older than 29 at commissioning (waivers possible) Currently... 

SPECIALIZED RG

BD Manager Job at SPECIALIZED RG

Job Description: Responsible for contract signing, execution, after-sales follow-up, and technical services. Maintain existing customers, seek new customers, and develop and expand the market. Requirements: Ability to develop markets, with certain customer resources...

ABS Kids

Senior BCBA ($10,000 Bonus, Flexibility) Job at ABS Kids

 ...your clinical priorities Admin and scheduling support to keep your focus on client outcomesnot paperwork Free in-house and online CEUs, plus a generous annual stipend An organization founded and led by fellow BCBAswe speak your language A Culture... 

B&M Ashman

CATV Coax Splicer Job at B&M Ashman

Primary responsibilities include ability to splice/test/repair cables/wires in both indoor and outdoor settings, read, create and maintain splicing diagrams, Improve upon the performance ,functionality, reliability, or quality of existing products or trade processes; maintain...

Encompass Health Rehabilitation Hospital of Amarillo

Physical Therapist Assistant Job at Encompass Health Rehabilitation Hospital of Amarillo

 ...licensed therapists to help patients recover and improve...  ...medical plans, paid time off, tuition reimbursement...  ...the moment you become a part of our team. Being...  ...vision plans for both full-time and part-time employees...  ...Assistant you always wanted to be Channel your...