Jobs

Director Regulatory Affairs

The Job Responsibilities

• Key contact with all global agencies in Europe, the United States, and Canada for the Patient Monitoring business unit across the affected sites as well as other medical product manufactured by Draeger Medical Systems Inc. Serves as a point of contact to the FDA for Draeger in early guideline alignment
• Development of regulatory strategy and management of submissions to regulatory agencies, requiring working knowledge of Draeger Medical Systems, Inc. products and of relevant US and international regulations and guidance
• Responsible for staying up to date on any regulatory changes or updates and ensures Draeger Patient Monitoring adheres to regulatory regulations. Responsible for communicating regulatory changes and updates to key stakeholders in the organization
• Oversees industry-specific practices and ensures all government and company regulations are being met
• Ensures that regulatory requirements are understood and adhered by CFT’s
• Leads the Regulatory Affairs function and personnel to include performance management, training, development, budget, and special projects
• Advises corporate personnel regarding the development and implementation of regulatory strategy, potential areas of regulatory concern, and new government/regulatory developments
• Managing the transition to EU Medical Device Regulations to ensure continued business with existing products and timely new product CE marking
• Implements the requirements of applicable approval and registration relevant QMS standards, directives and regulations throughout Draeger Medical Systems Inc. as related to the Regulatory function
• Partnering closely with Product Development, Quality, Clinical Affairs, Management, and other areas of the organization to ensure timely and strategic submissions
• Provides guidance to the US Regulatory team in preparing and filing 510(k), and PMA submissions, FDA reports, responding to questions, and achieving timely clearance/approval for marketing. In addition to guiding the Regulatory team in preparing and filing technical documents for CE marking and international registrations, responding to questions, and achieving timely regulatory approval
• Performs other duties as needed and assigned

Your Qualifications

Education:

Bachelor’s Degree in a scientific discipline, life sciences, biomedical or other engineering science. Masters or PhD preferred.

Related Experience:

• Minimum of 15 years experience in medical device regulatory with at least five years in a management role
• Previous experience in risk management processes; auditor qualification a plus
• Demonstrated success in developing a proactive organization in regulatory compliant environment

Special Competencies or Certifications:

• Knowledge of current US and International regulations and guidelines to obtain approvals for the medical devices; specifically, knowledge about the requirements of the MDSAP countries
• Ability to develop, implement and manage an integrated regulatory compliant QMS
• Ability to lead multi-level and multi-discipline work teams to develop, implement and manage processes/business systems
• Effective verbal, written and presentation skills
• Strong influencing skills to lead the decision-making process with executive management, peers, and subordinates
• Knowledge of current quality management system requirements of main market counties for Dräger products

The Dräger Workplace

In North America, Draeger employees over 1,400 employees working in our major sites in the United States and Canada (in the US: Andover, MA; Telford, PA; Houston, TX, and in Canada: Mississauga, ON), including our Sales and Service workforce employees from coast to coast.

The design, development and manufacturing of Draeger’s Patient Monitoring product line takes place in our Andover, Massachusetts location.

Equal Opportunity Employer – Disability and Veteran

Who we are

Draeger is a leading international company in the fields of medical and safety technology. Whether in clinical applications, in industry, mining or emergency services: Draeger products protect, support and save lives. That’s what our more than 15,000 employees have been striving for – every day for more than 130 years. Dräger – Technology for Life ®

What we offer

• Health center and gym
• Flexible working time
• Company sports and prevention courses
• Contributions to (occupational) pension plans
• Professional development opportunities and coaching
• Health Insurance
• Retirement savings

Please contact Heidi Webster at heidi.webster@draeger.com for more information on how to apply.

Job posted: 2023-05-24