Regulatory Head of Medical Devices and Equipment 8/12/2016
JOB DESCRIPTIONAPPLY MilliporeSigma plays an integral part in the life science community, harnessing our passion and innovation to help researchers and drug producers around the world. As science advances, we advance with it, offering new insight and cutting-edge technologies helping our customers solve the world's most challenging human health issues. Our promise to our customers is that we'll be there every step of the way. MilliporeSigma is a division of Merck KGaA, Darmstadt, Germany. Merck KGaA, Darmstadt, Germany is a global pharmaceutical and chemical company with a history that began in 1668, and a future shaped by around 40,000 employees in 64 countries.
This employee will lead a global subject matter expert group for medical devices and in vitro diagnostic (IVD) devices.
* Integrate global regulatory knowledge throughout the product lifecycle with aspects of effective management and strategy development. Responsible for strategic planning and interfacing throughout the medical device and equipment lifecycle, both within the organization and with a diverse range of external groups.
* Leading and providing strategic regulatory guidance and delivering the global regulatory strategy for product development, manufacturing and registration on Medical Devices, Assays and Equipment.
* Building and maintaining a credible relationship with worldwide regulatory authorities with effective written and verbal communication related to registration of Medical Devices and Equipment.
* Carrying out regulatory registrations and listing. Compiling and carrying out regulatory submissions original, change submission and annual reporting for the Medical Device, Biologics and EEE portfolio. Supporting country groups in registration and listing activities.
* Manages numerous, potentially cross-discipline teams of professionals and is accountable for the performance and results of the teams.
* Provide guidance and coordinate registration / notification / listing activities together with the local regulatory units of the sites / local agents / subsidiaries. Develop and maintain systems for tracking and reporting product submissions, registrations, licenses, approvals, etc. of all IVDs, Medical Devices worldwide.
* Ensures that relevant changes to product registrations and listings are properly notified to the relevant authorities.
* Ensuring manufacturing sites and distribution comply with regulatory requirements and good regulatory practices.
* Responsible for vigilance reporting to Competent Authorities.
* Prepare regulatory assessments and regulatory action plans in the product development process (PDP)
* Interface/partner with Marketing, Commercials, Manufacturing sites, Operations, Distribution, Trade Compliance, R&D, QA, QC and Regional Regulatory units.
* Leading new global strategic Medical devices and Equipment regulatory projects within MilliporeSigma Life Science
* Provide regulatory support and guidance to marketing and commercials via seminars / trainings / events.
* Requires a graduate degree (e.g. pharmacist, chemist, biologist, engineer) that provides knowledge of theories, principles and concepts within Regulatory Management
* Requires extensive professional experience (approximately 10-15 years as a guide) including managerial experience in diverse roles.
* Requires depth and breadth of expertise combined with in-depth knowledge of market, competitors and authority landscape
* Requires extensive knowledge on a broad scope of regulations globally
* Excellent communication, negotiation and leadership skills
* Excellent project management skills
The Company is an Equal Employment Opportunity employer. No employee or applicant for employment will be discriminated against on the basis of race, color, religion, age, sex, sexual orientation, national origin, ancestry, disability, military or veteran status, genetic information, gender identity, or any other classification protected by applicable federal, state, or local law. This policy of Equal Employment Opportunity applies to all policies and programs relating to recruitment and hiring, promotion, compensation, benefits, discipline, termination, and all other terms and conditions of employment. Any applicant or employee who believes they have been discriminated against by the Company or anyone acting on behalf of the Company must report any concerns to his/her Human Resources Business Partner, Legal, or Compliance immediately. The Company will not retaliate against any individual because he/she made a good faith report of discrimination.