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Regulatory Affairs ensures compliance to medical device and IVD regulations globally. The Regulatory Affairs Department communicates with worldwide health authorities in the licensing of all products both in development or currently marketed globally. The Senior Regulatory Affairs Specialist will collaborate with Agilent international partners and subsidiaries to drive high profile regulatory submission projects. The person in this role will investigate complex global regulatory issues and will develop and execute strategic regulatory plans in countries outside of the US and EU.
Responsible for providing guidance and strategy for project teams for global regulatory submissions, registrations and/or licenses with regard to regional IVD regulations.
Collaborate closely with regulatory colleagues in the US, as well as international distributors and Agilent subsidiaries in EU, Eastern Europe, Middle East, Africa, Latin America and Asia Pacific. This may require non-traditional work hours.
Provide expertise in regulatory affairs leading to the successful regulatory registrations and approvals/registrations/licenses of Diagnostic products in global markets.
With Regulatory Management, develop regulatory strategies related to Diagnostic product development, including Companion Diagnostics.
Provide regulatory assessments and plans for international product registrations and approvals.
Interact and collaborate with regulatory bodies and pharmaceutical partners.
Ensure the accurate and timely preparation of regulatory submissions and reporting in accordance with Company goals, regulatory requirements and partnership contracts.
Work across the Agilent organization to ensure alignment of regulatory processes, standards and compliance.
Ensuring distributors meet external and internal regulatory and business requirements.
Provide expertise and advice in obtaining product registrations and approvals in the EEMEA, Latin America and AP.
Stay abreast of global IVD regulations and guidance and communicate across the organization.
Note: This position will not require writing of 510(k) or PMA submissions.
Yes, 10% of the Time
Carpinteria, CA, United States - 6392 Via Real
Bachelor's Degree in scientific or technical field, preferred biological sciences; advanced degree or regulatory affairs certification preferred.
Minimum 8 years related experience in Medical Devices, Pharmaceutical or In Vitro Diagnostic industry or within regulatory agencies.
Strong track record of successful international regulatory submissions and registrations.
Experience in In-Vitro Diagnostics, preferably Companion Diagnostics, and has lead company-sponsored interactions with international regulatory bodies.
Proven ability to drive multiple fast paced international regulatory submissions simultaneously.
Strong project management and project planning experience.
Special Skills Required:
Excellent written, verbal and presentation communication skills.
Ability to multi-task and manage priorities accordingly amongst several competing initiatives.
Ability to synthesize global regulatory requirements and plans in a concise manner.
Proven team leader with a desire to succeed under a minimum level of guidance.
Ability to lead/influence internal and external stakeholders at all levels in a matrixed team environment.
Creative problem solving skills and decision making abilities that adapt to change.
Promote teamwork across geographies and cultures.
Maintain team focus on quality while adhering to project timelines and goals.
Excellent working knowledge of Microsoft Office Applications (Word, Excel, Project, PowerPoint, Outlook), Sharepoint and remote meeting tools such as WebEx.
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