Regulatory Affairs Manager

Regulatory Affairs Manager in Carpinteria.
We are searching for an experienced regulatory manager to work within the Companion Diagnostics (CDx). 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 Manages employees responsible for implementation of regulatory activities, including regulatory submissions related to Companion Diagnostics. Directs, manages resources to implement tactical project plans and programs/ projects. Develops, implements solutions to department issues 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.
Benefits - Full Relocation Assistance Available - Yes
Commission Compensation - No Bonus Eligible - Yes
Overtime Eligible - No Interview Travel Reimbursed - Yes
7+ to 10 years experience Management Experience Required - No
Minimum Education - Bachelor's Degree Willingness to Travel - Occasionally
Hours Per Week:
40 Visa Candidate Considered:

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