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

Advocates for Trans Equality

Summer 2026 Legal Intern(s) Job at Advocates for Trans Equality

 ...transgender and non-binary people through impact litigation, direct legal services, advocacy, and public education. A4TE's Legal...  ...a role in our nation's movement for transgender rights. Summer legal interns will primarily assist the impact litigation and Trans Health... 

21st Century Personnel

Truck Driver Local Job at 21st Century Personnel

Local Truck DriverMUST live within 30 miles of Punta Gordato apply.MUST be willing to start off working nightsNow hiring experienced and...  ...daily. 2 runs per day.Tues - Sat: Off Sunday and MondayExperience Required:6 months solo OTR experience (after training) within... 

California Staffing Corporation

Sr QC Reviewer, LIMS Data Entry/Review Job at California Staffing Corporation

 ...States without sponsorship. Must be able to pass a comprehensive background check, which includes a drug screening. At Thermo Fisher Scientific, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission... 

Boston Children's Hospital

Clinical Social Worker, Thyroid Center, Boston Job at Boston Children's Hospital

Position Summary/Department Summary: Part time social work position (20 hrs.) needed to provide a range of clinical social work services in the BCH Thyroid Center. The BCH Thyroid Center is one of the first and largest centers in the United States exclusively devoted...

TradeJobsWorkforce

Police Records Specialist Job at TradeJobsWorkforce

 ...In this role, the Police Records Specialist, where you will assist with packaging, labeling, and preparing items for delivery, learn company products and services to better assist others, and help organize and maintain a tidy workspace. Additional duties include respond...