Full-Time
Senior Regulatory Affairs Specialist
Direct Staffing
No salary listed
Santa Clara, CA, USA
In Person
Category
 Legal & Compliance (2) |
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Requirements
- Bachelor's degree or Master's degree or equivalent; typically 8+ years of relevant experience for this level; post-graduate and/or certification/license may be required.
- Must have global regulatory experience working in in vitro diagnostic, medical devices or pharmaceutical sectors, with a history of successful regulatory submissions, registrations, 510(k)s and PMA approvals in the United States and Asia.
- Experience leading company-sponsored interactions with regulatory bodies, especially the U.S. Food and Drug Administration; regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts.
- Excellent oral and written communication skills; ability to represent Regulatory Affairs on project teams and collaborate with pharmaceutical partners.
- Provide regulatory expertise to achieve regulatory registrations and approvals of Companion Diagnostic products in global markets; ensure alignment of regulatory processes, standards and compliance across the organization; stay abreast of global IVD regulations and guidances, especially those relevant to Companion Diagnostics.
- Ability to interact and collaborate with pharmaceutical partners in joint meetings; represent the Company in third-party meetings and regulatory associations.
- Interacts with and provides regulatory assessments and plans for international product registrations and approvals; develops regulatory strategies related to CDx product development.
Responsibilities
- Provide expertise in regulatory affairs leading to successful regulatory registrations and approvals of Companion Diagnostic products in global markets.
- With Regulatory Senior Management, develop regulatory strategies related to Companion Diagnostics product development.
- Provide regulatory assessments and plans for international product registrations and approvals.
- Interact and collaborate with pharmaceutical partners in joint meetings.
- Ensure the accurate and timely preparation of regulatory submissions and reporting in accordance with company goals, regulatory requirements and partnership contracts.
- Work 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.
- Represent the Company in third-party meetings, especially the FDA, and regulatory associations.
- Stay abreast of global in vitro diagnostic regulations and guidances relevant to Companion Diagnostics.
Desired Qualifications
- Experience in Companion Diagnostics is preferred