Regulatory Affairs Manager - Corporate Quality (Irvine, CA

Company: Edwards Lifesciences Gruppe
Location: Irvine
Posted on: April 10, 2021

Job Description:

We have made changes to enhance your experience. If you have applied for a job previously, you will need to create a new account. Thank you for your patience. Regulatory Affairs Manager - Corporate Quality (Irvine, CA) USA - California - Irvine This Manager will provide Regulatory support and leadership to Edwards Lifesciences' Corporate Regulatory Affairs team and cross-functional teams. The role leads a Regulatory perspective to support Edwards' global Regulatory Compliance. This role provides opportunities for global interactions to create and lead solutions to enable patients' accessibility of life-saving products and therapies through a challenging yet fulfilling position. Key Responsibilities

• Drive Regulatory process improvements to support future digital strategy by leading, facilitating, and collaborating with cross-functional teams to establish a Regulatory platform
• Facilitate and 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
• Further build Corporate RA's capability helping to establish the necessary Regulatory infrastructure through core processes, systems, and people skills/knowledge in support of the strategic business intent now and into the future
• 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
• Provide guidance and feedback to Business Unit Regulatory Affairs teams based on Regulatory changes
• Provide guidance on process improvement/remediation projects based on prior experience and responses from international affiliates
• Lead compliance initiatives relating to Regulatory requirements
• Evaluate global directives, assess the ramifications to Edwards' business and develop Regulatory solutions. Will work closely with the Regulatory teams across the regions and businesses Qualifications
  • Bachelor's Degree in a related field (scientific discipline preferred) plus minimum of eight years of Regulatory Affairs experience within the medical device industry required (Masters Degree with a minimum of three years of Regulatory Affairs experience within the medical device industry)
  • Good knowledge of Regulatory operations including distribution control and submission of product data
  • Successful implementation with Product Lifecycle Management (PLM) system
  • 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
  • Good problem solving, organizational, analytical and critical thinking skills
  • Strict attention to detail
  • Ability to interact professionally with all organizational levels
  • Ability to manage competing priorities in a fast-paced environment
  • Must be able to work in a team environment, including immediate supervisor and other team members in the section or group
  • Ability to build and sustain stable working relationships internally E dwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. Posted 3 Days Ago Full time Req-7431 About Us Edwards Lifesciences is the global leader in patient-focused medical innovations for structural heart disease, as well as critical care and surgical monitoring. Driven by a passion to help patients, the company collaborates with the world's leading clinicians and researchers to address unmet healthcare needs, working to improve patient outcomes and enhance lives. Headquartered in Irvine, California, Edwards Lifesciences has extensive operations in North America, Europe, Japan, Latin America and Asia and currently employs over 15,000 individuals worldwide.-- For us, helping patients is not a slogan - it's our life's work. From developing devices that replace or repair a diseased heart valve to creating new technologies that monitor vital signs in the critical care setting, we focus on helping patients regain and improve the quality of their life.

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