Regulatory Affairs Consultant- Defined Term (Remote, US)

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 a remote position, 40 hours/week and for fixed term of one year.

Job Responsibilities and Essential Duties

• Prepare submission documentation to address Global Sales and Service Unit QRC requests that will be submitted to health authorities, and providing submission strategy/regulatory pathway development, testing requirements, and responding to deficiency questions from health authorities.
• Maintain product registration information and provide registration information to Regulatory management as requested.
• Develop and implement strategies for regulatory approval of medical devices.
• Communicate international submission and/or advertising and promotion requirements to internal customers such as product development teams and marketing/sales.
• 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.
• May participate in IFU development activities.
• Research regulatory requirements for assigned geographies. Monitor emerging trends and integrate new requirements into department procedure/forms.

Internal and External Contacts/Relationships

• Quality Department
• Engineering/Operations Department(s)
• Marketing/Sales Department(s)
• Worldwide Getinge and /or Distributor Regulatory Colleagues

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 four years Medical Device Regulatory Affairs experience is required.
• Must have proven experience knowledge of FDA and/or international regulations.
• Must have solid understanding of product development process and design control.
• Must have 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.

This position is Exempt and does not participate in the company bonus program.

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.