Director, International Regulatory Affairs TMTT

Edwards Lifesciences • Irvine, CA

1d • $174,000 - $246,000 • Onsite

About The Position

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. Patients with mitral and tricuspid heart valve disease often have complex conditions with limited treatment options. Our Transcatheter Mitral and Tricuspid Therapies (TMTT) business unit is boldly pursuing an innovative portfolio of technologies to address a patient’s unmet clinical needs. It’s our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

Requirements

• Bachelor's Degree and related experience or equivalent work experience based on Edwards criteria
• Demonstrated track record of people management
• Experience working in a medical device, pharmaceutical or RA company
• Ability to travel up to 30% internationally

Nice To Haves

• Master's Degree and a minimum of 10 years related experience or equivalent work experience based on Edwards criteria
• Experience working in a healthcare company, regulatory affairs and medical device
• Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices
• Expert knowledge and understanding of global regulatory requirements for new products or product changes
• Expert knowledge of new product development systems
• Represents leadership on projects within a specific area interfacing with project managers and regulatory affairs team
• Consult in project setting within specific regulatory affairs area
• Provides regulatory affairs leadership to outsourcing partners on a task level, and may participate on small scale RFP
• Proven successful project management leadership skills
• Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines
• Knowledge of financial mechanism that relates to budget forecast and profit & loss

Responsibilities

• Plan registration activities (including labeling) with accountability for successful completion within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access and provide regulatory support for global product registration projects
• Manage and oversee the work of regulatory affairs and may have financial budget responsibilities with a focus on: Reviewing promotional materials to comply with local regulatory requirements
• Submitting local clinical trials and SAE reporting (adverse events)
• Product launch activities
• Maintaining local notifications database
• Analyzing information on product recalls from field corrective action team (EW global quality team) and provide reports to government
• Analyze local regulatory trends and market intelligence information; advise and make recommendations to International regulatory affairs team on the potential high impact risks and change implementation; participates in the creation of local regulatory affairs strategy and build and maintain relationships with local regulatory authorities and national and regional trade associations; acts as a point of contact for regulatory authorities.
• Provide active participants in national and regional Trade Assoc
• Manage a team and develop a robust talent development plan in alignment with functional growth strategies of the department
• Identify and evaluate more complex process improvements in regulatory affairs (especially regarding registration and labelling) and/or course correction/alignment opportunities
• Educate employees on regulatory affairs impact (e.g. registration of new products).
• Define and communicate guidelines for business partners

Benefits

• competitive salaries
• performance-based incentives
• a wide variety of benefits programs to address the diverse individual needs of our employees and their families
• medical or religious accommodation for exemption from the vaccination requirement

What This Job Offers

• Job Type: Full-time
• Career Level: Director