Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs

About This Role

This Regulatory Affairs Specialist position provides regulatory support and leadership to Edwards Lifesciences' Corporate Regulatory Affairs team and cross-functional teams. The role offers a global perspective to support Edwards' worldwide Regulatory Compliance, creating solutions to enable patient accessibility to life-saving products and therapies.

Responsibilities

• 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 the impact of proposed and current global regulations and proposing suggestions for expediting approvals
• Assist Business Unit Regulatory Affairs & Functional teams in 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

Requirements

• Bachelor's degree and minimum of three years of Regulatory Affairs experience within a highly regulated industry OR Master's degree with at least one year of Regulatory Affairs experience within a highly regulated industry; or equivalent work experience based on Edwards' criteria

Nice to have:

• 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
• 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

Benefits

• Performance-based incentives
• Wide variety of benefits programs to address the diverse individual needs of employees and their families