Senior Regulatory Affairs Manager in Cincinnati, Ohio at Mammotome

Date Posted: 11/6/2019

Job Snapshot

Job Description

Job ID: MAM000666

About Us

At Mammotome, we are committed to providing best-in-class technology to help clinicians accurately diagnose breast cancer. We provide clinicians devices spanning the breast cancer diagnostic care continuum from tissue biopsy to accurate lesion removal, never forgetting that at the heart of each breast cancer diagnosis is the patient. Through our ever-expanding product portfolio we strive every day to improve the patient’s journey and achieve better outcomes. Headquartered in Cincinnati, Ohio, the Mammotome brand is sold in over 50 different countries throughout the world. 



Description

Mammotome (also known as Devicor Medical Products, Inc.) is a world leader in the field of breast tissue biopsy.  The Sr. Manager of Regulatory Affairs (RA) provides expertise and management of the Regulatory Affairs function for the Mammotome business. Responsible for a broad spectrum of global regulatory needs, including premarket and postmarket regulatory affairs to support Mammotome’s growing business. This individual must possess strong leadership, strategic and technical skills.  She or He will work hand in hand with their Quality Assurance colleagues, engineering (R&D) and marketing to ensure best-in-class regulatory strategy and compliance.


Major Responsibilities 
  • Leadership of Mammotome’s Regulatory Affairs function including management of a global team of RA Managers, supervisors and professionals.
  • Develops team members and drives engagement according to Danaher tools and principles (e.g. D4G, P4G, engagement).  
  • Is accountable for the performance and results of all Mammotome regulatory responsibilities, including but not limited to:  (i) regulatory strategies and RA input to product development programs, (ii) ensuring compliance to applicable regulations (e.g. EU Medical Device Regulation, MDR), (iii) leading global RA team on behalf of market approvals and registrations, (iv) post market regulatory including management of adverse events (i.e. MDRs, Vigilance), (v) assessment and management of field actions and recalls, and (vi) responsible for review and approval of labeling, advertising and promotion according to regulations and corporate standards (e.g. MAPSS).  
  • Leads the regulatory aspects of Mammotome clinical trials/clinical evaluations while collaborating with the Global Clinical Affairs team.  
  • Develops and implements plans for the Mammotome Regulatory Affairs group according to the priorities of the business.  Drives on-time execution of all regulatory activities and projects. 
  • Manage timelines, budgets and resource allocation according to requirements of the business.
  • Stays current on regulatory intelligence and changes that impact the Mammotome business.  
  • Effectively use Danaher Business System (DBS) tools to drive continuous improvement.

Critical Success Factors: 
  • Strong leadership skills – ability to lead and develop team members; holds people accountable
  • Independent self-starter – capable to prioritize and manage work and responsibilities independently
  • Effective communication and group facilitation – drive data analysis to decisions and actions among broad cross-functional groups and various levels of the organization
  • Conflict resolution – ability to directly address conflicts and drive consensus toward positive results
  • Results oriented – has track record of delivering results, takes ownership and is accountable
  • Stretch oriented – embraces and thrives on challenge
  • Continuous improvement oriented – participates in Kaizen events, has familiarity with lean principles and how to apply them to value streams
  • Customer Service oriented – high sense of urgency
  • Proven ability to manage the organizational culture challenges associated within a multi-site company.
  • The ability to drive process rigor, accountability, and execution in a global environment, utilizing the tool box of the Danaher business system. 
  • Shows excellent cross-functional communication skills both up and down and deals with organizational conflict in a productive and effective manner.  Is exceptionally clear and concise.

Job Requirements



Qualifications

  • Bachelor’s degree in engineering or comparable technical field. Graduate degree is highly preferred.   
  • At least 8+ years’ experience with increasing responsibility in medical device regulatory affairs.  
  • Formal training in global medical device Regulatory Affairs.  Professional certification through RAPs, or equivalent, is highly desirable.
  • Deep understanding of global medical device regulatory requirements and practical experience in implementing or managing such activities.   
  • Related experience includes 4+ years managing people, preferably in a global environment
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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, environmental and applied solutions. Our globally diverse team of 71,000 associates is united by a common culture and operating system, the Danaher Business System, which serves as our competitive advantage. We generated $19.9B in revenue last year. We are ranked #162 on the Fortune 500 and our stock has outperformed the S&P 500 by more than 5,200% over 25 years.
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