At a Glance
- Tasks: Guide innovative technologies through complex regulatory environments to improve patient lives.
- Company: Join a leading medical device company dedicated to enhancing cardiac surgery.
- Benefits: Competitive salary, performance incentives, and diverse benefits programmes.
- Other info: Dynamic team environment with opportunities for professional growth and development.
- Why this job: Make a real difference in patients' lives while working on cutting-edge medical technologies.
- Qualifications: Bachelor’s degree and 3 years of relevant experience in regulatory affairs.
The predicted salary is between 74000 - 104000 £ per year.
Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients’ lives. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open‑heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients’ quality of life and expand their potential treatment opportunities. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.
Key Responsibilities
- Represent the regulatory function on manufacturing and product development teams, providing input on regulatory requirements, presenting alternatives for meeting regulatory requirements, resolving conflicts between those requirements and development issues, and reporting to management.
- Prepare and oversee documentation packages for submission to global regulatory agencies.
- Track timelines and document milestone achievements for inclusion in regulatory submissions.
- Interact with regulatory agencies as part of submission review and on‑site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
- Provide guidance on regulatory requirements necessary for contingency planning.
- Monitor proposed and current global regulations and guidance; assess the impact of such regulations and guidance on assigned projects and propose suggestions on utilizing regulatory updates to expedite the approval process.
- Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
- Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions.
Required Qualifications
- Bachelor’s Degree and a minimum of 3 years related experience (or equivalent experience based on Edwards criteria).
- Relevant coursework, seminars, and/or other formal government and/or trade association training.
Preferred Qualifications
- Bachelor’s Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering).
- Experience in preparing domestic and international product submissions.
- Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
- Solid knowledge and understanding of global regulatory requirements for new products or product changes.
Benefits
Competitive salaries, performance‑based incentives, and a wide variety of benefits programs. Base pay range for California: $74,000 – $104,000 (highly experienced). Pay depends on qualification, education, and prior experience.
EEO Statement
Edwards is an Equal Opportunity/Affirmative Action employer including protected veterans and individuals with disabilities.
Specialist, Regulatory Affairs Surgical in Redhill employer: Edwards Lifesciences Gruppe
At Edwards, we are committed to making a meaningful difference in patients' lives through innovative technologies in cardiac surgery. Our collaborative work culture fosters employee growth and development, offering competitive salaries and a comprehensive benefits package that reflects our dedication to our team. Join us in California, where you can be part of a mission-driven environment that values your expertise and encourages you to thrive in the regulatory affairs landscape.
Contact Details:
Edwards Lifesciences Gruppe Recruitment Team
StudySmarter Expert Advice🤫
We think this is how you could land Specialist, Regulatory Affairs Surgical in Redhill
✨Tip Number 1
Network like a pro! Reach out to people in the industry, attend relevant events, and connect with professionals on LinkedIn. We can’t stress enough how personal connections can open doors that applications alone can’t.
✨Tip Number 2
Prepare for interviews by researching the company and its products. Understand their regulatory processes and be ready to discuss how your experience aligns with their needs. We want you to shine and show them why you’re the perfect fit!
✨Tip Number 3
Follow up after interviews! A simple thank-you email can set you apart from other candidates. It shows your enthusiasm and keeps you fresh in their minds. We believe a little courtesy goes a long way!
✨Tip Number 4
Don’t forget to apply through our website! It’s the best way to ensure your application gets seen by the right people. Plus, we love seeing candidates who are proactive about joining our mission to improve patients’ lives.
We think you need these skills to ace Specialist, Regulatory Affairs Surgical in Redhill
Some tips for your application 🫡
Tailor Your Application:Make sure to customise your CV and cover letter to highlight your experience in regulatory affairs, especially in surgical or medical device contexts. We want to see how your skills align with our mission to improve patients' lives!
Showcase Your Attention to Detail:Since this role requires a keen eye for detail, include examples in your application that demonstrate your ability to manage complex documentation and regulatory requirements. We love candidates who can spot the little things that make a big difference!
Highlight Relevant Experience:Don’t forget to mention any specific experience you have with global regulatory submissions or working with regulatory agencies. This will help us see how you can contribute to our innovative technologies right from the start.
Apply Through Our Website:We encourage you to submit your application through our website. It’s the best way for us to receive your details and ensures you’re considered for the role. Plus, it shows you’re serious about joining our inspiring journey!
How to prepare for a job interview at Edwards Lifesciences Gruppe
✨Know Your Regulations
Make sure you brush up on the latest global regulations relevant to medical devices, especially Class II and III. Being able to discuss these in detail will show your technical mastery and attention to detail, which are crucial for this role.
✨Prepare Your Documentation Skills
Since you'll be preparing and overseeing documentation packages, practice explaining how you've successfully managed similar tasks in the past. Bring examples of your work that demonstrate your ability to ensure compliance and accuracy in submissions.
✨Engage with Real Scenarios
Think about potential conflicts between regulatory requirements and product development issues. Be ready to discuss how you would resolve these conflicts, as this shows your problem-solving skills and understanding of the regulatory landscape.
✨Show Your Passion for Patient Care
This role is all about making a difference in patients' lives. Be prepared to share why you're passionate about regulatory affairs in the surgical field and how you see your work impacting patient outcomes. This personal touch can really resonate with interviewers.
