SR. REGULATORY AFFAIRS SPECIALIST
Company: Direct Staffing Inc
Location: Santa Clara
Posted on: January 19, 2023
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
Direct Staffing Inc
Keywords: Direct Staffing Inc, Santa Clara , SR. REGULATORY AFFAIRS SPECIALIST, Other , Santa Clara, California
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