SR. REGULATORY AFFAIRS SPECIALIST

Sr. Regulatory Affairs Specialist

We are searching for an experienced regulatory professional to work within the Companion Diagnostics (CDx) team of Dako North America. 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

• Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals of Companion Diagnostic products in global markets.
• With Regulatory Sr. Management, develops regulatory strategies related to CDx product development.
• Provides regulatory assessments and plans for international product registrations and approvals.
• Interacts and collaborates with pharmaceutical partners in joint meetings.
• Ensures the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts.
• 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.
• Represents the Company in 3rd party meetings, especially the FDA, and regulatory associations.
• 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.