Senior Regulatory Affairs Specialist (Wayne, NJ)

With a passion for life

Join our diverse teams of passionate people and a career that allows you to develop both personally and professionally. At Getinge we exist to make life-saving technology accessible for more people. To make a true difference for our customers - and to save more lives, we need team players, forward thinkers, and game changers.

Are you looking for an inspiring career? You just found it.

Job Overview

Responsible for activities which lead to and maintain regulatory approval to market medical devices. Additionally, is responsible for assessment of device and labeling changes for regulatory implications.

The position is hybrid and reports to the Wayne NJ office 3-4 days a week.

Job Responsibilities and Essential Duties

• Lead submission activities for a variety of device regulatory approvals including US premarket submissions (IDE, 510(k), PMA, etc.), international design dossiers/technical files, post-approval reports, export certificates, clinical trial exemptions and establishment registrations and listings.
• Maintain product registration information and provide registration information for management review activities.
• Serve as Regulatory Subject Matter Expert on issues such as recalls, advertising and promotional activities, field actions or review of proposed device changes.
• Participate in training and mentoring of staff
• Identify, develop and drive in department/systems development initiatives
• Maintains state license requirements and works with 3rd party contractors to obtain and renew state licenses for US BA entities, and resolve complex issues.
• Develop, maintain and drive positive relationships with U.S. FDA, EU Notified Body, and global regulatory agencies through oral and written communications regarding pre-submission strategy/regulatory pathway development, testing requirements, clarification, and follow-up of submissions under review.
• Develop and deliver presentations to global regulatory agencies. Topics may include submission strategies, compliance issues or new initiatives such as Global Harmonization. Coordinate comments on proposed regulations.
• Develop and implement strategies for regulatory approval of medical devices.
• Communicate submission and/or advertising and promotion requirements to internal customers such as product development teams and marketing/sales.
• Acts as a core team member on R&D teams, providing Regulatory Affairs feedback and guidance throughout the product development cycle.
• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes.
• Responsible for preparation and submission of routine regulatory applications, as well as internal regulatory file documentation.
• Reviews and signs-off on product and manufacturing changes for compliance with applicable regulations.
• Participate in IFU development activities
• Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedure/forms.
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  Required Knowledge, Skills, and Abilities

  
  
  
  
  • Bachelor's Degree in a scientific or technical discipline is required or equivalent work experience. Advanced degree preferred.
  • A minimum of six years Medical Device Regulatory Affairs experience is required.
  • Must have proven experience knowledge of FDA and international regulations.
  • Must have solid understanding of product development process and design control.
  • Must have solid understanding of IEC 60601, 62366, 62304
  • Must have solid understanding of regulations applicable to the conduct of world-wide recalls and field actions.
  • Must be able to manage or lead several projects simultaneously.
  • Must demonstrate effective research and analytical skills.
  • Must demonstrate effective written and verbal communication, including technical writing skills.
  • Must be able to work independently with minimal supervision.
  • Proficiency with Microsoft Office Products such as Word, Excel and Power Point or equivalent software applications is preferred.
    
    The base salary for this position is a minimum of $110,000 and a maximum of $120,000 plus 10% STIP as annual bonus
  
  
  
  

#LI-Hybrid #LI-YA2

About us

With a firm belief that every person and community should have access to the best possible care, Getinge provides hospitals and life science institutions with products and solutions aiming to improve clinical results and optimize workflows. The offering includes products and solutions for intensive care, cardiovascular procedures, operating rooms, sterile reprocessing and life science. Getinge employs over 12,000 people worldwide and the products are sold in more than 135 countries.

Reasonable accommodations are available upon request for candidates taking part in all aspects of the selection process.