Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs

Edwards Lifesciences Gruppe; Irvine (CA); On-site; USD 74,000 - 104,000; Full time

Job summary

Edwards Lifesciences is recruiting a Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs in Irvine, CA to lead regulatory support for global compliance and liaise with international affiliates.

You will drive regulatory process improvements, monitor global regulatory changes, and advise on strategies to expedite approvals while supporting FDA device listings and state renewals.

Qualifications

• Bachelor’s degree with 3+ years regulatory affairs experience in a regulated industry.
• Master’s degree with 1+ year regulatory affairs experience in a regulated industry.
• Equivalent experience per Edwards’ criteria.

Responsibilities

• Support the implementation of regulatory process improvement projects with key stakeholders and international counterparts.
• Monitor regulatory changes globally and provide guidance on strategies and contingency planning.
• Assist on FDA device listings, establishment registrations, and California licenses renewals as needed.
• Provide regulatory guidance for global product changes and new product development from a regulatory perspective.
• Support cross-functional teams and international affiliates to comply with regulatory requirements.

Skills

Regulatory affairs knowledge

Regulatory intelligence

Communication skills

Microsoft Office

Education

Bachelor's degree

Master's degree in regulatory affairs

Tools

Microsoft Office Suite

Job description

Innovation starts from the heart. Edwards Lifesciences is the leading global structural heart innovation company, driven by a passion to improve patient lives. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. Our Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs position is a unique career opportunity that could be your next step towards an exciting future.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. The role provides opportunities for global interactions to create and support solutions to enable patients’ accessibility of life-saving products and therapies through a challenging yet fulfilling role.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 complianceSupport the Regulatory Intelligence and Standards Management programs to identify, observe and analyze Regulatory changes as early as possible that may impact Edwards’ business globallyGather 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 approvalsAssist Business Unit Regulatory Affairs & Functional teams towards implementing Regulatory changesAssist on process improvement/remediation projects and responses from international affiliatesSupport FDA device listings, establishment registrations and the State of California Manufacturing Renewal Licenses, as neededSupport compliance initiatives relating to Regulatory requirementsProvide support to supervisor as neededWhat 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 disciplineMedical Device, Pharma, or Biotechnology industry experienceISO 13485:2016 certification, coursework, seminars, and/or other formal government and/or trade association training is preferredGood knowledge and understanding of global Regulations relevant to medical devices, medium risk (i.e. Class II) and/or high risk (i.e. Class III) devicesGood knowledge and understanding of global Regulatory requirements for new products or product changesGood knowledge of new product development systemsGood written and verbal communication skills with people of various international backgrounds and good interpersonal relationship skillsProven expertise in Microsoft Office Suite including Word, PowerPoint and ExcelAligning our overall business objectives with performance, we offer competitive salaries, performance-based incentives, and a wide variety of benefits programs to address the diverse individual needs of our employees and their families.For California (CA), the base pay range for this position is $74,000 to $104,000 (highly experienced).The pay for the successful candidate will depend on various factors (e.g., qualifications, education, prior experience). Applications will be accepted while this position is posted on our Careers website.Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.