Forecasted Opportunity: Senior Specialist, Regulatory Affairs

Make a meaningful difference to patients around the world. From design to production, our Regulatory Affairs teams help guide our innovative technologies through complex US and EU 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.

Aortic stenosis impacts millions of people globally, yet it often remains under-diagnosed and under-treated.  Edwards’ groundbreaking work in transcatheter aortic heart valve replacement (TAVR) pioneered an innovative, life-changing solution for patients by offering heart valve replacement without the need for open heart surgery. Our Transcatheter Heart Valve (THV) business unit continues to partner with cardiologists and clinical teams to transform patient care with devices supported by clinical evidence. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Please note this is a high-engagement, office-based position on Edwards’ beautiful campus in Irvine, California.    

This is an evergreen requisition. We are posting this opportunity in anticipation of a future opening.

How you will make an impact:

• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions. Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.
• Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans

• Prepare documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking Technical Documentation and GSPR).

• Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process
• Review product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy
• Other incidental duties

What you’ll need (Required):
 

Bachelor's Degree in a related field and 5 years of previous related experience

Or

Master’s Degree in a related field and 3 years of previous related experience

Coursework, seminars, and/or other formal government and/or trade association training
 

What else we look for (Preferred):

• Bachelor’s or Master’s degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) or Engineering discipline
• Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices, with focus on US and EU regulatory requirements
• Full knowledge and understanding of global regulatory requirements for product changes.
• Experience in preparing domestic and international product submissions
• Excellent written and verbal communication skills including negotiating and relationship management skills
• Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel
• Excellent problem-solving, organizational, analytical and critical thinking skills
• Good leadership skills and ability to influence change
• Strict attention to detail
• Ability to interact professionally with all organizational levels
• Ability to manage competing priorities in a fast paced environment
• Ability to work in a team environment, including inter-departmental teams
• Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations
• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
   

Aligning our overall business objectives with performance, we offer competitive salaries, perform