Director Global Regulatory Affairs & Quality Assurance - Medical Device Commercial Ops
August 22, 2018
Full Time - Experienced
4 Year Degree
The Beckman Coulter Life Sciences Director of Global Regulatory Affairs and Quality Assurance is responsible for strategic and operational leadership for the Regulatory Affairs function globally across multiple product development / manufacturing sites as well as Commercial Regulatory and Quality Assurance for China.
Globally, this position will provide direction for regulatory affairs programs including new product development, global registrations, advertising and promotional materials, product labeling, post market regulatory compliance and adapting to new/changing regulatory requirements. In China, this position will oversee the quality management system, quality assurance program for warehouse and distribution functions, reagent and instrument product registrations, regulatory agency certification for storage and distribution of In Vitro Diagnostic medical devices.
Build and develop a high performing regulatory affairs and quality assurance team
Provide strategic direction for new product development regulatory strategies aimed at improving time to market globally
Direct and oversee commercial regulatory and quality operations in China
Direct and oversee the regulatory and quality planning processes with responsibility for strategic and tactical planning processes
Oversee and ensure efficient processes for global registrations and post market compliance
Oversee program to ensure readiness for EU IVDR compliance
Direct and oversee program for review and approval of marketing communication materials
Monitor project progress and provide reporting on a regular basis to executive management to ensure timely execution of regulatory strategies to support launch activities and compliance status for maintenance projects and activities
Participate in corporate councils setting strategy for meeting changing regulatory requirements and driving projects across the operations to implement required changes efficiently and effectively
Collaborate across the organization at all levels, across functional groups and geographic locations, including executive management; manage matrices effectively
Utilize Danaher Business System (DBS) tools to drive compliant and effective processes; improve capability to support market growth
Develop resourcing strategies, allocates budgets, staff, tools and support necessary for efficient and compliant operations
Required Skills & Experience
Bachelor’s degree in areas of life sciences, engineering, or quality assurance; advanced degree preferred
Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQM, CQE, CQA, RAC, CLIA, Six Sigma, Lean Principles)
20 years’ experience in a regulated medical device/diagnostic industry (fewer years’ required with advanced degree)
10 years’ supervisory and management experience
Demonstrated experience in developing organizational capability
Proven track record of bringing together the quality and regulatory functions across multiple locations to create an organization that supports the business worldwide
Demonstrated successful experience negotiating complex premarket and post market regulatory strategies with FDA, CFDA and other regulatory agencies
Demonstrates knowledge of domestic and international quality systems and other standards such as FDA QSR, MDD, INVIMA, ANMAT, ANVISA, COFEPRIS, ISO 13485, ISO 9001 and other applicable standards and regulations
Knowledge of design control process requirements and requirements for technical documentation for medical devices
Global experience leading and/or participating on cross functional teams
Additional Salary Information: Will relocate
Internal Number: 0001051
About Beckman Coulter
At Beckman Coulter, we are dedicated to advancing and optimizing the laboratory. For more than 80 years, we have been a trusted partner for laboratory professionals, helping to advance scientific research and patient care. We do challenging work on a global scale, and are invested in growing our associates’ careers. We embrace continuous improvement, and are passionate about moving science and healthcare forward.
We have a vital role at Beckman Coulter: our focus on innovation, reliability and efficiency has led us to become the partner of choice for clinical, research and industrial customers all over the world.
Beckman Coulter is a Danaher company, operating in two industries: Diagnostics and Life Sciences.