Regulatory Affairs Specialist, Regulatory Intelligence & Corporate Regulatory Affairs

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

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs Specialist in Regulatory Intelligence & Corporate Regulatory Affairs to support global regulatory compliance and cross-functional teams. The role provides a regulatory perspective to enable patient access to life-saving devices and therapies.

The candidate will engage with international counterparts, manage regulatory changes, and contribute to process improvements while aligning with business objectives.

Qualifications

• Bachelor’s degree and minimum of 3 years of Regulatory Affairs experience in a highly regulated industry OR Master’s degree with at least 1 year of Regulatory Affairs experience in a highly regulated industry.
• Experience with global medical device regulations and readiness for regulatory submissions.
• Knowledge of global Regulations relevant to medical devices (Class II/III) and product changes.

Responsibilities

• Provide regulatory support and leadership to Edwards Lifesciences’ Corporate Regulatory Affairs team and cross-functional teams.
• Assist on regulatory process improvement projects and remediation with international affiliates.
• Support FDA device listings, establishment registrations, and state licensure requirements as needed.
• Prepare guidance on regulatory strategies and contingency planning for worldwide regulatory requirements.

Education

Bachelor's degree in Regulatory Affairs or related field

Master's degree in Regulatory Affairs or related field

Tools

Microsoft Office (Word, PowerPoint, Excel)

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 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

Aligning 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.