Regulatory Affairs Specialist

Organization
Agilent Technologies
Job Location
Carpinteria, CA
Job Description

Dako North America, an Agilent Technologies Company
Location: California (Carpinteria)
We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team of Dako North America, an Agilent Technologies company. 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 prefered 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 Agilent 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.

Requirements

Bachelors or Masters Degree or University Degree or equivalent.
5-6 years relevant experience
Post-graduate and/or certification/ license may be required.
Requires specialized depth and/or breadth of expertise in job.

Geo Location: Carpinteria, CA

Agilent Technologies Inc. is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, disability or any other protected categories under all applicable laws.

Students whose classmates are interested in science are more likely to think about a career in science, technology, engineering, and mathematics, a new study says.

CNBC reports that the genetic counseling field is expected to grow as personalized medicine becomes more common.

Gladys Kong writes at Fortune that her STEM background has helped her as a CEO.

Social scientists report that the image of the 'lone scientist' might be deterring US students from STEM careers.