At a Glance
- Tasks: Lead regulatory strategies for innovative AI software in women's health ultrasound.
- Company: Join GE HealthCare, a leader in healthcare innovation and inclusivity.
- Benefits: Competitive salary, diverse work culture, and opportunities for professional growth.
- Other info: Collaborative environment with a focus on career development and global impact.
- Why this job: Make a real impact in healthcare by ensuring compliance and driving innovation.
- Qualifications: Experience in regulatory affairs, especially in AI software; strong communication skills.
The predicted salary is between 60000 - 80000 £ per year.
As a Regulatory Affairs Leader, you will be supporting GE HealthCare's Women's Health Ultrasound business. You will be collaborating closely with the AI feature design team in our Zipf site, as well as with the global regulatory team. You will be responsible for providing regulatory strategy and direction to the business regarding healthcare industry regulatory requirements for product launch, premarket submissions/registrations and postmarket compliance, working closely with healthcare regulatory bodies globally.
Roles and Responsibilities
- Provide regulatory leadership and strategic direction for Ultrasound regulatory AI Software programs, including global RA support for registration planning, submissions, notified body and quality system audits, and program implementation across a cross-functional team with communication to leadership.
- Support compliance of premarket submissions/registrations and post market compliance, working closely with healthcare regulatory bodies globally.
- Develop regulatory strategies to help optimize 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.
- Utilise technical expertise and judgement to solve problems.
- Assess changes in existing products and determine the need for new / revised licenses or registrations.
- Review and approve advertising and promotion material to ensure consistency with approved claims and regulatory requirements.
- Contribute to writing and editing technical documents.
- Research, analyze, integrate and organize background information from diverse sources for regulatory submissions.
- Apply regulatory requirements and understand their impacts on submissions and pre- and post-market compliance.
Required Qualifications
- Proven experience working in a regulated field, especially AI software; advanced practical experience in the Quality & Regulatory Affairs.
- Bachelor's degree in software engineering, regulatory affairs or equivalent.
- Strong oral and written communication skills.
- Demonstrated ability to analyze and resolve problems.
- Ability to document, plan, market, and execute programs.
- Established project management skills.
- Strong communication skills.
Additional Information
- Relocation Assistance Provided: No
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.
Regulatory Affairs Leader employer: Meeveem Limited
At GE HealthCare, we pride ourselves on being an exceptional employer, particularly for our Regulatory Affairs Leader role at our innovative Zipf site. Our collaborative work culture fosters creativity and growth, offering employees the chance to engage with cutting-edge AI technology in women's health ultrasound. With a commitment to professional development and a focus on inclusivity, we provide a supportive environment where your contributions directly impact global healthcare solutions.
StudySmarter Expert Advice🤫
We think this is how you could land Regulatory Affairs Leader
✨Join Compliance Communities
Get involved in compliance and risk communities — both online and offline. Look for forums, LinkedIn groups, or even local meetups where compliance pros hang out. You never know who might drop a job opportunity your way!
✨Attend Industry Conferences
Keep an eye out for compliance and risk management conferences and workshops in your area. These events are a goldmine for networking, and they often have job boards or recruiters on-site looking for new talent. Plus, it’s a chance to learn what's trending in the field.
✨Leverage Your University Career Services
If you’ve recently graduated or are still studying, head over to your university's career services. Many companies, including those in compliance, actively recruit fresh talent through these services, so make sure you tap into that resource.
✨Showcase Your Knowledge Online
Start writing articles or blog posts about compliance topics that interest you. Share them on platforms like LinkedIn to demonstrate your knowledge and passion. This not only builds your presence in the field but can also catch the attention of companies like Meeveem Limited looking for candidates who are engaged and informed.
We think you need these skills to ace Regulatory Affairs Leader
Some tips for your application 🫡
Show Your Understanding of Compliance:In the compliance-risk field, it's super important to showcase your understanding of regulations and risk management frameworks. Highlight any relevant coursework, certifications (like ICA or AML), or even projects that demonstrate your knowledge and commitment to this area. We want to see how you can navigate this complex landscape!
Quantify Your Achievements:When detailing your experience, try to quantify your achievements. For example, if you've previously worked on a project that improved compliance metrics or reduced risk exposure, give us the numbers! This data-driven approach really stands out to hiring managers in compliance-risk roles.
Tailor Your CV to Reflect Relevant Skills:Make sure your CV highlights skills that are particularly relevant to compliance, like attention to detail, analytical thinking, and report writing. Ensure these are easy to spot – consider using bullet points to break down your responsibilities and achievements for maximum impact!
Craft a Motivating Cover Letter:In your cover letter, let us know why you’re excited about the compliance-risk role at Meeveem Limited. Share what motivates you about compliance, and how you believe you can contribute to our mission. This is your chance to showcase not only your skills but also your passion for this important field!
How to prepare for a job interview at Meeveem Limited
✨Master the Regulations
Brush up on key compliance regulations relevant to the industry you're applying to. Familiarising yourself with specific laws and frameworks used in your field will give you an edge during technical questions. Show that you’re not just aware of them but can also apply them—think real-life scenarios!
✨Show Your Analytical Skills
Compliance roles really focus on analytical skills, so be prepared for case studies or situational questions during the interview. We've got to demonstrate how we approach risk assessments or compliance audits, possibly drawing on examples from past experiences or university projects. Bring some thoughtful case scenarios to discuss!
✨Know Your Tools
Get comfortable with commonly used compliance software and tools. Familiarity with platforms like RSA or MetricStream can really impress during your interview, as it shows you're ready to hit the ground running. If you’ve had any experience with them, make sure to highlight that!
✨Align with Company Culture
Since it's a full-time position, show your long-term commitment and interest in the company’s mission and values. Dive into how your ethics and professional philosophy align with Meeveem Limited’s stance on compliance. A shared vision can really resonate with interviewers looking for fit as much as skill!
