Job description
Director Regulatory Affairs
Oversee the Regulatory Affairs activities in Agilent enterprise and Agilent businesses including Dako.
Develop the global organizational regulatory strategies, implement and monitor the regulatory strategies and activities.
Evaluate current processes & procedures and implement new and necessary improvements and additions.
Build up of an efficient organization that supports premarket, postmarket and regulatory operations including global submissions and regulatory support of clinical trials and reimbursement activities.
Support current development and partner programs.
Support product investigations and safety analyses on critical product issues.
Build rapport with global regulatory bodies and develop external global regulatory network to support activities.
Represent company as regulatory expert externally and internally.
Education and provide expert guidance to organization.
Ensure regulatory risks are mitigated with business regulatory plans are developed and maintained for all products.
Leadership over regulatory organization and accountability to regulatory budget.
Primary Internal
Project Management, R&D Management, Medical/Clinical Affairs Management, Marketing Management, Quality Management and business heads including senior management.
Primary External
Regulatory authorities, external clinical study sites including review boards or other partners involved in development projects or product modifications including pharma partners, FDA and other external organizations including universities as appropriate.
Duties And Responsibilities
Leadership over the development of critical global pre-market activities such as regulatory strategies, reimbursement strategies, submission requirements and strategies, labeling requirements and associated regulatory risk identification and mitigation.
Ensure product improvements, corrections, post-market studies and analyses are performed in a compliant, comprehensive and timely manner including the support of product risk safety analyses such as vigilance/MDR decision trees and post market report development.
Ensure clinical studies/trials are initiated, approved, monitored and reported according to global regulatory requirements (IRBs, ethics committees, study population, biostats, etc.).
Ensure seamless coordination with internal and external partners to obtain regulatory clearance and partnership approval of regulatory strategies.
Oversee Regulatory Affairs global organization
Ensure quality system(s) meet global regulatory requirements and is maintained to meet current standards and global business expectations.
To ensure personnel are capable of guiding businesses on regulatory requirements and resourced to support both business priorities and compliance issues.
Drive functional strategies for Regulatory Affairs including integration of the Product Regulatory Affairs organization.
Qualifications
BS degree required, MS degree a plus
+ years of relevant work experience
Prefer minimum of 5 years of experience in IVD/medical device industry with at least 3 years of experience of in higher classification submissions, e.g. US class III PMAs
Prefer minimum of 5 years of experience working in mixed product environment: medical device, pharma, non-medical/clinical regulated
Prefer global management experience across multiple time zones and cultures
Desire experience in the area of companion diagnostics and/or co-development projects
Prefer international regulatory knowledge and submission experience
Experience in giving high level presentations externally and internally
Strong communication skills
Structured, well organized and flexible
High work capacity may be required at certain times in high priority projects.
Experience working with external international partners
Advanced communication skills, both written and spoken
Willing to travel as required to meet job expectations estimated between 30-40%
Geo Location: Santa Clara, CA
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Friday, September 18, 2015
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