Manager, Regulatory Affairs
|Posted on:||Monday, July 20, 2015|
|Organization:||Ortho Clinical Diagnostics|
Interprets regulatory requirements and determines the strategy to obtain registrations. * Independently makes decisions regarding work processes or operational plans and schedules in order to achieve department and project objectives. * Represents OCD to domesticInternational regulatory agencies and interact with Health ministry personnel to expedite pending applications, resolve regulatory matters, and manage development meetings for regulatory submissions. * Provides guidance to business partners regarding regulatory requirements including indications of risk and approximate timing for approvals for planning purposes. * Supports both new product development and currently marketed product portfolio within a line of business. * Independently executes activities related to maintaining compliant regulatory status for marketed products including annual reporting, change management, labeling review, etc. * Actively represents OCD in External influence activities with Industry Trade associations, Standardization organizations etc. to stay abreast and impact policies and standards applicable to the OCD business. * Maintains good working relationships with Product Development, Product Support, Operations, Marketing and Quality Partners. * Maintains collaborative relationships with Regulators, Trade and Standards Organizations, External business partners, i.e. 3rd party suppliers, Product developers, contractor manufacturers. * Performs other work related duties as assigned.
* A minimum of Bachelor’s degree in a Scientific or related Discipline is required, BSMT is a plus * Minimum of 8-10 years of experience in an FDA regulated Medical Device Industry required, IVD Industry experience preferred. * A working knowledge of US, EU, and International Regulations, FDA, etc. and guidance for Medical Devices, specifically IVDs required. * Experience developing regulatory strategies and an understanding of Product Development is preferred. * Excellent interpersonal, teamwork and verbalwritten communication skills are required. * Good organizational skills and an ability to manage multiple tasksprojectspriorities and complex systems simultaneously are required. * The ability to demonstrate model behavior, to understand priorities and to encourage others to drive for results will be needed. * Ability to mentor junior level staff as well as cross-train with peers is preferred. * The ability to work with business partners across geographies and time zones is critical. * Up to 20% domestic and international travel may be required. Join us on the Journey Let’s get started Apply today or refer a friend Equal Opportunity: Ortho-Clinical Diagnostics, Inc. is an equal opportunity employer, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, national origin, protected veteran status, or disability status, or any other characteristic protected by law.