Specialist, Regulatory Affairs Surgical

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex domestic and international regulatory environments. Working in partnership with external government and regulatory authorities, and alongside diverse internal stakeholders, your close attention to detail and technical mastery will help ensure our products reach clinicians and improve patients' lives. Dedicated to innovation, our Surgical business unit is focused on identifying and solving critical, unmet needs in cardiac surgery. In understanding the challenges of open heart surgery, we partner with surgical teams to deliver modern technologies intended to enhance patients' quality of life and expand their potential treatment opportunities. It's our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Key Responsibilities

• Represent the regulatory function on manufacturing and product development teams, providing input on regulatory requirements, presenting alternatives for meeting regulatory requirements, resolving conflicts between those requirements and development issues, and reporting to management.
• Prepare and oversee documentation packages for submission to global regulatory agencies.
• Track timelines and document milestone achievements for inclusion in regulatory submissions.
• Interact with regulatory agencies as part of submission review and on site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs, and CE marking design dossiers and technical files).
• Provide guidance on regulatory requirements necessary for contingency planning.
• Monitor proposed and current global regulations and guidance; assess the impact of such regulations and guidance on assigned projects and propose suggestions on utilizing regulatory updates to expedite the approval process.
• Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
• Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions.

Required Qualifications

• Bachelor's Degree and a minimum of 3 years related experience (or equivalent experience based on Edwards criteria).
• Relevant coursework, seminars, and/or other formal government and/or trade association training.

Preferred Qualifications

• Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry, Bioengineering).
• Experience in preparing domestic and international product submissions.
• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.

Benefits

• Competitive salaries, performance based incentives, and a wide variety of benefits programs.
• Base pay range for California: $74,000 - $104,000 (highly experienced). Pay depends on qualification, education, and prior experience.

EEO Statement

Edwards is an Equal Opportunity/Affirmative Action employer including protected veterans and individuals with disabilities.