Regulatory Specialist, Medical Devices

Contribute to a Safer, More Secure, and More Sustainable World. At UL, we know why we come to work. Thousands of us around the world wake up every day with one common purpose - to make the world a safer, more secure, and more sustainable place to live. We clear the way for our customers to introduce the latest products, technological advances, and systems in an increasingly complex world so they can provide peace of mind to the market. Our integrity is woven throughout our company and shapes the way we approach and deliver our solutions. We are proud that the work we do every day has a meaningful contribution to society. We continue to build upon our legacy of trusted expertise and partnership to keep our communities safe and secure as we march forward into the future. This helps us to sleep better at night, and we are confident that the millions of people we touch rest easier too.   Responsibilities Responsible for managing the implementation of significant projects involving complex systems or multiple deliverables within a department or functional area. Plans and directs program schedules and budgets. Monitors program from project initiation through delivery, interfacing with stakeholders on applicable matters. Oversees the coordination of program/project activities generally within a department or functional area. Organizes interdepartmental activities ensuring completion of the program on schedule and within budget constraints. Assigns and monitors work of program staff.   The Role: To manage the CE MDD/IVDD certification scheme within the UL Notified Body To support Notified Body clients and the management of their CE regulatory projects To support Notified Body assessments, and support the Notified Body with regulatory submissions To provide support in handling client enquiries and the coordination of the delivery Notified Body certification services Key Responsibilities & Accountabilities: Manage and coordinate CE MDD/IVDD certification and regulatory projects Conduct contract reviews and support the CE application process Conduct change notification reviews, recertification reviews and other certification activities that do not require prior medical device product knowledge Support and drive client regulatory projects and enquiries Qualifications University degree in Business Administration, Engineering or related field plus generally eight years of directly related experience in medical device regulations (notified Body, other certification assessment body, or manufacturer) Prior knowledge of, experience with the MDD or IVDD or other medical device regulatory scheme Experience auditing medical device manufacturers or experience within a QMS role. Knowledge of business processes and the application of quality management standards. Awareness of the application of accreditation/designation, notified body, product and quality systems standards and requirements; a good understanding of product certification concepts, principles and service orientation Demonstrated ability to facilitate customer meetings, negotiate and influence outcomes; ability to be "customer friendly" whilst maintaining strict adherence to regulatory requirements Strong verbal and written communication skills; ability to build and foster relationships with internal and external customers Strong program/project management and leadership skills to manage projects utilizing personnel from multiple disciplines. Ability to identify and manage priorities as demonstrated by the ability to establish, track and meet schedules for multiple projects while maintaining high quality and exceptional customer service. Must be able to adapt in challenging situations and have the ability for critical and analytical thinking 2018-10930
Salary Range: NA
Minimum Qualification
8 - 10 years

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