Danaher Corporation Staff Regulatory Affairs Specialist - Ad Promo Med Devices in Miami, Florida

Danaher Company Description
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.

Description

This key staff level position is equivalent to a manager/individual contributor and provides strategic input into the review and approval of FDA-compliant commercial advertising and promotion campaigns and pre-commercialization activities for all products. The Staff Regulatory Affairs Specialist serves as the regulatory lead and provides sound regulatory advice that minimizes the risk of regulatory and legal action, while competitively positioning products to meet company business objectives. This role serves as an internal expert on FDA regulations, guidance, and enforcement trends governing the promotion of IVD medical device products and provides consultative support to project teams for strategies/issues related to development and commercialization objectives.

The Staff Regulatory Affairs Specialist is responsible for review and approval of advertising and promotional materials, including sales aids, sales training materials, social medial, journal ads, reprints, etc. The Staff Regulatory Affairs Specialist works collaboratively with colleagues in Medical Affairs, Legal, Marketing, and Compliance providing regulatory expertise to ensure development of promotional and non-branded materials which meet business policies/procedures. The Staff Regulatory Affairs Specialist role relies on extensive experience and judgment to plan, track, and accomplish goals, encompassing a variety of labeling, advertising and promotion tasks and working with various multidisciplinary team members. Creativity and flexibility are expected, and good communication and organizational skills are essential.

Qualification

Required Skills & Experience

  • Bachelor’s degree with 5 years of experience, Master’s degree with 3 years of experience, or Doctoral degree with 2 years of experience in life sciences, engineering, or quality assurance
  • Professional designations are not required but training and certificates in quality or regulatory affairs would be a plus (e.g. CQE, CQA, RAC, Six Sigma, Lean Principles)
  • Comprehensive understanding of manufacturing processes, chemistry and engineering principles
  • Subject matter expertise in regulatory affairs for medical devices and in vitro diagnostics
  • Demonstrated knowledge and understanding of regulations and guidelines governing the areas of medical devices and in vitro diagnostics
  • Experience in registration and commercialization of medical device and diagnostic products
  • Possess a broad knowledge of surrounding areas including Quality Assurance, Manufacturing and Development.
  • Demonstrated track record of developing organizational understanding and capability as it applies to regulatory affairs.
  • Global experience leading and/or participating on cross functional teams

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.

Organization: Beckman Coulter - Diagnostics
Job Function: Quality and Regulatory Affairs
Primary Location: North America-North America-United States-FL-Miami
Schedule: Full-time
Req ID: BEC011089