Lead Specialist, Regulatory Affairs, PCS – DigitalGE Healthcare, Pohjois-Savo
28.1.2024https://duunitori.fi/tyopaikat/tyo/lead-specialist-regulatory-affairs-pcs-digital-sgseh-17784185
Job description
Job Description Summary In this role you will create and manage global regulatory submissions for digital products such as Software as a Medical Device (SaMD) in the GE HealthCare Patient Care Solutions business. This will include providing strategic regulatory requirements for digital product launch, premarket submissions/registrations, and post market compliance.
GE HealthCare is a leading global medical technology and digital solutions innovator. Our mission 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.
Job Description Roles and Responsibilities
- Develops comprehensive regulatory strategies for digital products including SaMD (Software as a Medical Device) and Health IT applications under minimal supervision.
- Navigates evolving global regulatory requirements to facilitate and maintain market access. Assesses changes in existing products to determine the need for new / revised global licenses or registrations.
- Identifies regulatory requirements for product launch, authors premarket submissions/registrations, and performs change assessments in accordance with business timelines.
- Collaborates across the regulatory organization and cross functionally with Engineering, Clinical, and Scientific, to support global submissions in key markets.
- Reviews and approves advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
- Manages multiple projects, effectively prioritizes regulatory deliverables, and aligns cross-functional team expectations to ensure optimal outcomes.
- Takes initiative in identifying and resolving regulatory holds, submissions issues, regulatory queries and escalates to management accordingly.
Basic Qualifications
- Bachelor’s degree in a Scientific, Engineering, Computer Science, core Life Science discipline, or a combination of training and experience demonstrating the equivalent
- Minimum of 3 years combined work experience in heavily regulated fields such as medical devices, pharmaceuticals, or biologics, with a minimum of 2 years’ experience in Regulatory Affairs.
- Adept at utilizing research tools and capable of synthesizing complex information to support submissions and decision-making processes.
- Strong project management, communication, and interpersonal skills.
- Demonstrated experience and proficiency with MS Office word processing, spreadsheet, presentation, Adobe Acrobat, project management and collaboration applications.
Desired Characteristics
- Experience with Software as a Medical Device (SaMD), cybersecurity, artificial intelligence, and working knowledge of applicable standards and guidance including IMDRF SaMD framework, ISO 13485, IEC 62304, etc.
- Experience with high risk, life supporting, and life-sustaining products preferred.
- Advanced degree in scientific, technology or regulatory affairs disciplines.
- Regulatory Affairs Certification (RAC) issued by the Regulatory Affairs Professionals Society (RAPS).
- Learning oriented and eager to obtain new skills and knowledge. Demonstrates flexibility in understanding new and evolving regulations.
- Humility in understanding, but assertive when needed.
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.
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.
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Additional Job Description
For U.S. based positions only, the pay range for this position is $82,400.00-$123,600.00 Annual. It is not typical for an individual to be hired at or near the top of the pay range and compensation decisions are dependent on the facts and circumstances of each case. The specific compensation offered to a candidate may be influenced by a variety of factors including skills, qualifications, experience and location. In addition, this position may also be eligible to earn performance based incentive compensation, which may include cash bonus(es) and/or long term incentives (LTI). GE HealthCare offers a competitive benefits package, including not but limited to medical, dental, vision, paid time off, a 401(k) plan with employee and company contribution opportunities, life, disability, and accident insurance, and tuition reimbursement.
Additional Information
Compensation Grade
LPB2
GE HealthCare offers a great work environment, professional development, challenging careers, and competitive compensation. GE HealthCare is an Equal Opportunities Employer. 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.
GE HealthCare will only employ those who are legally authorized to work in the United States for this opening.
While GE HealthCare does not currently require U.S. employees to be vaccinated against COVID-19, some GE HealthCare customers have vaccination mandates that may apply to certain GE HealthCare employees.
Relocation Assistance Provided: Yes