Sr Regulatory Affairs Associate - Medical Device in Cincinnati, Ohio at Mammotome

Date Posted: 6/22/2018

Job Snapshot

Job Description

Job ID: MAM000526

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.


Devicor Medical Products, Inc. is an equal opportunity employer. We evaluate qualified applicants without regard to race, color, national origin, religion, gender, age, marital status, disability, veteran status, sexual orientation, gender identity, or any other characteristic protected by law.

All employment offers are contingent upon successful completion of our pre-employment drug screening and background/criminal check.


Description

The Senior Regulatory Affairs Associate provides support to the Senior Manager, Regulatory Affairs for US and Canada regulatory activities, including CFG requests, Establishment Registration submissions, 510k submission file maintenance, product and process change assessments, labeling review, and general regulatory documentation requests.


Essential Functions:



  • Provides support for US and Canada market product registration activities (e.g., PreMarket Notification [510(k)], PreMarket Approval (PMA), New/Amended Medical Device License Applications)


  • Works with project teams for New Product Development, Sustaining, and VAVE projects to ensure alignment of business needs and regulatory requirements by providing regulatory input through the lifecycle of the project


  • Assists global partners with the preparation of regulatory documentation, including completing literature searches to support submissions.


  • Completes review of labeling content, product and process changes, and product documentation


  • Maintains regulatory files in a format consistent with requirements.


  • Manages facility licensing activities (e.g., Establishment Registrations, Product Listings, Export Certificates (Certificates to Foreign Governments [CFGs])


  • Develops processes and checklists, and creates procedures to assure early visibility for regulatory requirements related to claims identification and substantiation, labeling, promotional materials, and assuring the validity of clinical, ethical and regulatory compliance issues.


  • Works with Global Regulatory counterparts to assure product compliance internationally


  • Provides regulatory support for internal and external (Regulatory Agency) audits, and assists with resolving observations


  • Evaluates and implements procedures pertaining to corporate and departmental regulatory activities

Job Requirements



Qualifications

Required Skills & Experience




  • Bachelor’s Degree required, preferably in Science/Technology, Biomedical Engineering, or a clinical field

  • Professional certifications (i.e., CQM/OA, RAB, RAPS) preferred

  • Minimum of 6 years’ regulatory experience in the food, drug, or device industry, preferably related to medical device license/clearance requirements



  • History of success in making change and achieving objectives required.


  • Successful track record working in a matrix/collaborative environment required


  • Software system familiarity, including Learning Management Systems, Document Management Systems, Database systems (e.g., ComplianceWire, Documentum, Microsoft Access)


  • Must be able to travel up to 10% of the time; both domestic and international travel is required


  • Typical work related travel assignments range 3-5 days, and as such overnight, out-of-town stays are required

General Skills/Competencies/Specialized Knowledge




  • Customer Orientation – Demonstrates a keen understanding of various customers’ (internal or external) needs and utilizes a variety of Devicor resources to provide solutions and a compelling value proposition.

  • Project Management – Ability to plan, organize and manage resources to bring about the successful completion of specific project goals and objectives. Works well within a metrics-driven environment

  • Healthcare Industry Knowledge – Understanding of key business issues that exist in the medical device and healthcare industries, i.e. health care economics and trends, state and local laws, regulatory requirements. Link and apply complex technologies to business strategies


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 62,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $16.9B in revenue last year. We are ranked #133 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 1,300% 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.