Regulatory Affairs Specialist, Corporate Regulatory
Edwards Lifesciences
Summary
The Regulatory Affairs Specialist position provides regulatory support and leadership to Edwards Lifesciences' Corporate Regulatory Affairs team and cross-functional teams. The role provides a Regulatory perspective to support Edwards' global Regulatory Compliance.
Job description
How you will make an impact
- Support the implementation of various Regulatory process improvement projects by working directly with key stakeholders in all business units as well as Edwards' international counterparts to accelerate market access routes and ensure compliance
- Support the Regulatory Intelligence and Standards Management programs to identify, observe and analyze Regulatory changes as early as possible that may impact Edwards' business globally
- Gather information to provide guidance on strategies and contingency planning with respect to worldwide Regulatory requirements, including assessing impact of proposed and current global regulations and proposing suggestions for expediting approvals
- Assist Business Unit Regulatory Affairs & Functional teams towards implementing Regulatory changes
- Assist on process improvement/remediation projects and responses from international affiliates
- Support FDA device listings, establishment registrations and the State of California Manufacturing Renewal Licenses, as needed
- Support compliance initiatives relating to Regulatory requirements
- Provide support to supervisor as needed
What You'll Need (Required)
- Bachelor's degree and minimum of (3) three years of Regulatory Affairs experience within a highly regulated industry OR Master's degree with at least (1) one year of Regulatory Affairs experience within a highly regulated industry; or equivalent work experience based on Edwards' criteria
What Else We Look For (Preferred)
- Degree in scientific discipline
- Medical Device, Pharma, or Biotechnology industry experience
- ISO 13485:2016 certification, coursework, seminars, and/or other formal government and/or trade association training is preferred
- Good knowledge and understanding of global Regulations relevant to medical devices, medium risk (i.e. Class II) and/or high risk (i.e. Class III) devices
- Good knowledge and understanding of global Regulatory requirements for new products or product changes
- Good knowledge of new product development systems
- Good written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
Requirements
- Bachelor's degree and minimum of 3 years of Regulatory Affairs experience within a highly regulated industry OR Master's degree with at least 1 year of Regulatory Affairs experience within a highly regulated industry; or equivalent work experience
- Degree in scientific discipline (preferred)
- Medical Device, Pharma, or Biotechnology industry experience (preferred)
- ISO 13485:2016 certification, coursework, seminars, and/or other formal government and/or trade association training (preferred)
- Good knowledge and understanding of global Regulations relevant to medical devices, Class II and/or Class III devices (preferred)
- Good knowledge and understanding of global Regulatory requirements for new products or product changes (preferred)
- Good knowledge of new product development systems (preferred)
- Good written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skills (preferred)
- Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel (preferred)
Benefits
- Competitive Salaries
- Performance-Based Incentives
- Wide Variety of Benefits
Company overview
Edwards Lifesciences (NYSE: EW) is the leading global structural heart innovation company, driven by a passion to improve patient lives. Founded in 1958 and headquartered in Irvine, California, the company specializes in developing breakthrough technologies for cardiovascular diseases. As a pioneer in the medical device industry, Edwards focuses on transcatheter heart valves, surgical heart valves, hemodynamic monitoring systems, and vascular solutions. The company's patient-focused culture inspires its 16,000+ employees worldwide to deliver life-changing innovations that address complex heart health challenges. Edwards serves patients in over 100 countries through its comprehensive portfolio of products including the SAPIEN transcatheter heart valve system, INSPIRIS surgical valves, and advanced monitoring technologies. With a commitment to research and development, the company invests 17-18% of its revenue back into R&D efforts, maintaining its position at the forefront of structural heart innovation. Edwards Lifesciences has impacted over one million patients globally through its transformative medical technologies.