You are here
Director Regulatory Affairs Europe
Senior and hands on role for a Senior Director Regulatory Affairs
Experience and proven trackrecord in the Diagnostics and Life Science Industry
About Our Client
Our client is an important global player, providing clinical diagnostics and life science research products. With a team
of almost 8.000 employees and a global network of operations serving their customers, our client helps people live longer and
Reporting for the Global VP - Regulatory and Quality, your main responsibilities will be:
* Provide leadership and strategic direction in regulatory affairs to support the timely registration /
regulatory clearance / regulatory approval of products;
* Partner with the Clinical Diagnostics Group senior Management, including R&D and Marketing
teams, to develop and implement effective (timely, cost effective) registration strategies for products;
* Proactively interact with registration bodies for the purposes of negotiating cost effective and timely
commercialization pathways for products;
* Work closely with Division Marketing and Commercial Selling organizations to facilitate prioritization
and execution of registration strategies;
* Stay current and communicates important regulatory issues and requirements to the Clinical Diagnostics Group and Global Supply Chain management. Partner with senior Global RA/QA management peers to continuously
improve and harmonize product submission processes in response to evolving requirements;
* Work with the Clinical Diagnostics Group management to implement consistent and compliant processes for the
review and approval of promotional activities (print/web advertising, trade shows, scientific publications, etc.) both prior to, and following, receipt of regulatory clearances/approvals;
* Partner with Global QA teams to support domestic and international complaint reporting requirements. Include overseeing subsidiary, customer, and regulatory authority notifications for adverse events, field safety corrective actions, and other related activities.
The Successful Applicant
* Education: Bachelor's Degree. Advanced degree preferred.
* Experience: 10 years relevant industry experience and a five years supervisory /management experience.
* Extensive knowledge of regulations applying to in vitro diagnostic products and associated instrumentation, with focus on European registrations. Experience with Russian and Chinese registration processes as well as US FDA knowledge are highly desirable.
* Proven management skills and demonstrated ability to effectively communicate (written and oral) with individuals to attain desired goals are necessary.
* Ability to effectively establish project priorities and delegate with appropriate authority.
* Ability to create, innovate, and anticipate changing needs and adapt in a timely way.
* Ability to analyze diverse scientific and regulatory issues and draw risk-based conclusions regarding the best path for introducing products to market.
What's on Offer
We are offering a competitive salary package for a director level.