Regulatory Compliance Lead

COMPANY DESCRIPTION

Santen is a specialized pharmaceutical company with a 130-year heritage focused exclusively on ophthalmology. With sales in over 60 countries, Santen’s 4,000 global employees work to deliver life-changing therapies that make hope a reality for people facing vision impairment and loss. Santen Inc., located in Emeryville, CA (North America HQ), contributes important research & development and commercialization efforts. This office is home to about half of our 300-total staff in North America, including our Toronto, Canada site and our recent acquisitions of Eyevance Pharmaceuticals (Fort Worth, TX) and InnFocus (Miami, FL).

We are in search of top talent to help us meet our important goals and large growth plans.

ABOUT THE POSITION:

Responsibilities of the Regulatory Compliance Lead include liaising with Santen affiliates to help ensure compliance with global complaint and medical device reporting regulations, and conducting corporate complaint and adverse event reporting compliance audits. The position will be situated in the US, and interact directly with Santen manufacturing sites in the US and with Santen affiliate entities in Europe and Asia to help ensure that the required complaint and adverse event information is compiled and reported within the timeframes prescribed in the Santen device manufacturers’ complaint and adverse event reporting procedures. In this role, the RCL may participate in preparing adverse event submissions and ad hoc reports, as well as serving as an information resource on assigned projects.

ESSENTIAL DUTIES AND KEY DELIVERABLES:

• Complaint and vigilance liaison, i.e., act as the conduit between the Santen affiliates in Europe and Asia, and the US medical device manufacturers’ complaint handling functions, to:
  1. Facilitate medical device complaint and adverse event information exchange between the US device manufacturer(s) and the Santen affiliates in the EU and Asia
  2. Support the medical device manufacturers’ product complaint handling and submission specialists with regard to the receipt of complaint/adverse event information, follow up requests for information and the return of medical devices for investigation
• Support configuration, implementation, and management of Santen complaint, safety tracking and reporting systems (TrackWise, Aris G).
• Provide direct adverse event submission support to medical device manufacturers (i.e., preparation and submission of domestic and international medical device incident reports (MDI) or medical device reports (MDR)), as required
• Provide support to device manufacturers during regulatory report preparation (e.g., Periodic Safety Update Report or PMSR), as required
• Write SOPs to describe processes for medical device assessment and analysis
• Serve as a subject matter expert as it pertains to complaint and adverse event regulations, as required
• Conduct annual corporate audits to assess compliance with medical device domestic and international complaint and adverse event reporting regulations at:
  1. Santen affiliates in Europe and Asia (compliant complaint reporting)
  2. Medical device manufacturers (complaint processing, investigating, file maintenance and domestic/international adverse event reporting)
• Provide assistance approving, reviewing, and contributing to publications (abstracts, posters, papers) for scientific meetings/journals, as required
• Develop a succession plan for RCL position
• Provide support for regulatory authority audits and for product recall activities, as required
• Participate in the creation of the departmental organizational strategy, goals, and objectives, and assist in the implementation of the departmental business plans to support both local and global safety strategies (i.e., rollout of new adverse event/vigilance initiatives).
• Collaborate with other departments (e.g., training) to provide expertise and guidance to personnel for interdepartmental and cross-functional team activities.
• Interact with Santen affiliates and service providers to share best practices and discuss new/revised complaint and adverse event regulations, as required

QUALIFICATIONS:

• College degree with a minimum of four years medical device industry complaint/adverse event reporting experience
• Ability to effectively communicate business and compliance objectives with cross-functional multi-region offices
• Demonstrated knowledge of domestic and global medical device reporting regulations (e.g., FDA, EU and Asia Pacific region )
• Demonstrated knowledge and proficiency with quality management system/safety databases (e.g., TrackWise, Aris, Mastercontrol, etc.)
• Proficiency with standard office skills and standard desktop computing programs including spreadsheets and presentations
• Excellent oral and written communication skills with excellent interpersonal skills and willingness to work in a global cross-functional team environment
• Highly organized and demonstrated understanding of workflow prioritization
• Ability to multitask and triage as needed, with the ability to work independently and under pressure, while demonstrating initiative and flexibility
• Strong attention to detail as well as technical and problem-solving skills
• Strong project management skills
• Knowledge of ophthalmic physiology helpful

For more information about our company and the work experience, please visit www.santenusa.com