Senior QRA Associate - EU/EMEA (m/f) in Nationwide Germany at Mammotome

Date Posted: 11/5/2018

Job Snapshot

Job Description

Job ID: TAS000077

About Us

In December 2014, Devicor® Medical Products, Inc. was acquired by Leica Biosystems, part of the Danaher family of companies. Leica Biosystems is the global leader in anatomic pathology solutions and automation, striving to advance cancer diagnostics to improve patients’ lives. The combination of the two companies uniquely positions us to develop integrated patient-to-pathology solutions for the diagnosis of cancer.

Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. Mammotome remains committed to its heritage of advancing technology for early detection of breast cancer, providing support and education for clinicians worldwide, and offering breast care information for patients

Description

  • Partners with the Quality and Regulatory Team, Corporate Engineering, Sales and Marketing to develop cohesive registration planning for existing products, new products and product and facility changes.
  • Provides local support for registration and licensing requirements as they apply to products and services of the company both domestically and internationally, as well as facility licensing activities pertinent to EU/EMEA.
  • Reviews and approves labeling for compliance, including all communications to trade publications, news media release, sales presentations and technical bulletins specific to EU/EMEA
  • Collaborates and assists Global Regulatory (European Authorized Representative) to support product compliance internationally.
  • Identifies specific EMEA Regulatory legislation, develops strategies for compliance, and provides monthly updates of upcoming changes.
  • Maintains the list of relevant Harmonized Standards.
  • Working with the Global Quality and Regulatory Affairs to ensure international vigilance processes and management for Product Surveillance (distributor and direct sales and service) are relevant, effective, and maintained.
  • Executes all associated activities for compliance to EU/EMEA vigilance reports reporting regulations.
  • Provides key support for EU business locations and maintains electronic files and access to Quality and Regulatory technical documentation and product labeling to support tenders and Quality and Regulatory requests.
  • Other duties as assigned.

Job Requirements



Qualifications

  • Bachelor’s Degree required, preferably in a Science or Engineering field.
  • Professional certifications (i.e., CQM/OA, RAB, RAPS) preferred
  • Minimum of 4 years of experience managing complaint management processes in the medical device or related industry required (e.g., QSR (21 CFR 820) and ISO/EC (MDD, ISO 13485)).
  • Knowledge and understanding of FDA regulations and reporting requirements for medical device complaints, including MDR reports required.
  • Knowledge of EU Medical Device Directives, Canadian Medical Device Regulations and other International Regulations strongly preferred.
  • Knowledge of the requirements for international quality systems, including ISO 13485, MDD, Vigilance Systems, Notified Bodies, CE marking and IEC 60601 strongly preferred.
  • Experience interacting with Health Care Professionals, patients, and consumers to complete and close complaint investigations strongly preferred.
  • Experience with complaint management software systems and databases preferred.
  • Basic understanding of statistical tools strongly preferred



Danaher Corporation Overview

Danaher is a global science & technology innovator committed to helping our customers solve complex challenges and improve quality of life worldwide. Our world class brands are leaders in some of the most demanding and attractive industries, including life sciences, medical diagnostics, dental, environmental and applied solutions. Our globally diverse team of 67,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $18.3B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,200% over 20 years.
At Danaher, you can build a career in a way no other company can duplicate. Our brands allow us to offer dynamic careers across multiple industries. We’re innovative, fast-paced, results-oriented, and we win. We need talented people to keep winning. Here you’ll learn how DBS is used to shape strategy, focus execution, align our people, and create value for customers and shareholders. Come join our winning team.