Senior Regulatory Affairs Consultant

2 weeks ago


Santa Clara, California, United States Direct Staffing Inc Full time

Position Overview:
We are seeking a highly skilled regulatory professional to join our Companion Diagnostics (CDx) team. The successful candidate will report to the Sr. Director of Regulatory Affairs (CDx) and must possess extensive global regulatory experience in In Vitro Diagnostics (IVD), Medical Devices, or Pharmaceuticals, with a proven track record of successful regulatory submissions, registrations, 510(k) clearances, and PMA approvals in both the United States and Asia.

Key Responsibilities:
1) Provide specialized knowledge in regulatory affairs to ensure successful registrations and approvals of Companion Diagnostic products in international markets.
2) Collaborate with Regulatory Senior Management to formulate regulatory strategies pertinent to CDx product development.
3) Conduct regulatory evaluations and devise plans for international product registrations and approvals.
4) Engage and collaborate with pharmaceutical partners during joint meetings.
5) Guarantee the precise and timely preparation of regulatory submissions and reporting, aligning with company objectives, regulatory standards, and partnership agreements.
6) Work cross-functionally to ensure consistency in regulatory processes, standards, and compliance. Offer expertise and guidance in securing CDx product registrations and approvals in the Asia-Pacific region.
7) Represent the organization in third-party meetings, particularly with regulatory agencies and associations.
8) Remain informed about global IVD regulations and guidelines, especially those relevant to Companion Diagnostics.

Qualifications:
A Bachelor’s or Master’s degree, or equivalent educational background is required. Typically, a minimum of 8 years of relevant experience is expected for entry to this level. Additional postgraduate qualifications and/or certifications may be necessary. This role demands specialized depth and/or breadth of expertise in the field, and it is not a natural progression from an advanced level.

Additional Information:
All personal information will be maintained confidentially in accordance with EEO guidelines.



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