Regulatory Affairs Program Manager

24 Apr, 2022

Jobs

Regulatory Affairs Program Manager

IBM
Remote

Introduction
At IBM, work is more than a job – it’s a calling: To build. To design. To code. To consult. To think along with clients and sell. To make markets. To invent. To collaborate. Not just to do something better, but to attempt things you’ve never thought possible. Are you ready to lead in this new era of technology and solve some of the world’s most challenging problems? If so, lets talk.

Your Role and Responsibilities
As Regulatory Affairs Program Manager and member of the Watson Health Compliance Organization you will support the Quality Management System and provide regulatory support of development programs for new and existing products. As a key member of the cross-functional product development teams that you support, you will actively collaborate to enable efficient and compliant, full life cycle product management to satisfy business, market, and regulatory requirements.

 

This position will be located in our Cambridge MA, Hartland WI or any Watson Health location.

Essential Job Duties:

  • Under minimal supervision, acts as company representative, developing and maintaining positive relationships with device reviewers through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification and follow up of submissions under review
  • Participates or leads FDA, notified body, and other regulatory inspections
  • Provides business impact analysis of trends in international regulatory developments and proposes course of action to Watson Health
  • Evaluates proposed products for regulatory compliance requirements internationally
  • Develops and implements global regulatory strategies for new and modified medical devices for intended markets as determined by the Product teams.
  • Prepares and submits regulatory applications, as well as internal regulatory file documentation to achieve market clearances in US, Canada and EU at a minimum
  • Acts as a core team member on manufacturing development teams, providing regulatory affairs feedback and guidance throughout the product development cycle
  • Reviews and signs-off on product/manufacturing changes for compliance with applicable regulations and guidance’s
  • Collaborates with regional business partners to support international product registrations
  • Assists with the development of regulatory department policy and procedure implementation
  • Reviews device labeling and promotional materials for compliance with global submissions and applicable regulations; analyzes appropriate changes
  • Performs all duties and responsibilities as required by the Quality Management System Policies and Procedures
  • Assists with activities related to the corrective and preventative action (CAPA) process
  • Build quality into all aspects of their work by maintaining compliance to all quality requirements
  • Leads cross functional teams for assigned projects
  • Coaches, mentors and trains junior staff members

Required Technical and Professional Expertise

  • Bachelor’s degree in a scientific or technical discipline required; advanced degree preferred.
  • Minimum of 15 years in the medical device industry in Regulatory Affairs
  • Proficient in preparing various types of regulatory submissions including 510(k), and EU Technical Files
  • Proficient in the preparation of Health Canada Medical Device Licenses
  • Must be well versed in the medical device quality system regulations and international regulatory requirements for medical devices
  • Proficient knowledge of global regulatory submission requirements for medical devices
  • Proficiency with Microsoft Word, Excel and PowerPoint
  • General understanding of product development process and design control
  • Excellent communication and interpersonal skills are essential

Preferred Technical and Professional Expertise

  • Advanced degree in a scientific or technical discipline
  • Experience with the preparation of US FDA PMA submissions
  • Effective research and analytical skills
  • Effective written and oral communication, technical writing and editing skills
  • Specific experience with software medical devices

Learn more here

Job posted: 2022-04-24