Regulatory Affairs Leader Handheld Ultrasound (Remote)

As Regulatory Affairs Leader, you provide regulatory input and strategies to directly support development projects and marketed Handheld Ultrasound products. The key responsibility is to develop and maintain the Regulatory and Quality sections of the EU Technical throughout the entire life cycle of a product, file US FDA 510(k)s, and work with regional regulatory colleagues to obtain clearance in global markets. The role requires strong technical knowledge and a good understanding of quality systems and global regulatory requirements. You will closely collaborate with global Engineering, Supply Chain, Site Manufacturing and Quality teams in Europe, India, China, and US. Candidates for this role are located near our site in Horten, Oslo, or Trondheim. Remote workers will be considered depending on availability of local candidates.

Job Description

GE HealthCare is a leading global medical technology and digital solutions innovator. Our purpose is to create a world where healthcare has no limits. Unlock your ambition, turn ideas into world-changing realities, and join an organization where every voice makes a difference, and every difference builds a healthier world.

Key Responsibilities

• Provides regulatory input for product development to ensure compliance to regulatory requirements for target markets;
• Develops regulatory strategies to help guide regulatory submission pathways, taking into consideration regulatory requirements (including product testing, clinical data, etc), product claims and country regulatory dependencies to ensure optimized sequencing for submissions;
• Works with a cross functional team to prepare and submit regulatory submissions to regulatory authorities for the purpose of obtaining authorization for market launch;
• Assesses changes in existing products to and determines the need for new / revised licenses or registrations;
• Develops plan for timely submission of renewal registrations for applicable countries per business plan, to ensure continued product supply in those countries;
• Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements;
• Contributes to writing and editing technical documents;
• Researches, analyzes, integrates and organizes background information from diverse sources for regulatory submissions;
• Understands and applies regulatory requirements and their impacts for submissions;
• Ensures compliance with pre- and post-market product approval requirements;
• Supports regulatory inspections as required;
• Assesses adverse events and field actions for reportability to regulatory authorities and prepares and submits reportable events and recalls in a timely manner to regulatory authorities, as per country regulations;
• Performs a broad variety of tasks in support of product and process design as assigned by the departmental manager.

Qualifications/Requirements

• Bachelor’s or Master degree in scientific, technology or legal discipline;
• Significant experience with EU CE marking and US FDA 510(k) submissions of medical devices;
• Where required by law the Technical Responsible will meet required qualifications in terms of education, certifications, and experience;
• Ability to communicate effectively in English (both written and oral).
• Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, and database applications.

Desired Characteristics

• Experience with medical devices, software algorithms and Deep Learning;
• Regulatory Affairs Certification (RAPS);
• Statistics education and or training;
• Ability to communicate effectively in Norwegian (both written and oral).

Inclusion and Diversity

GE HealthCare is an Equal Opportunity Employer where inclusion matters. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by law.

Behaviors

We expect all employees to live and breathe our behaviors: to act with humility and build trust; lead with transparency; deliver with focus, and drive ownership – always with unyielding integrity.

Total Rewards

Our total rewards are designed to unlock your ambition by giving you the boost and flexibility you need to turn your ideas into world-changing realities. Our salary and benefits are everything you’d expect from an organization with global strength and scale, and you’ll be surrounded by career opportunities in a culture that fosters care, collaboration and support.

Additional Information

Relocation Assistance Provided: No