Specialist, Regulatory Affairs Operations TMTT

Job description

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. How you will make an impact: Develop moderately complex Regulatory Affairs process improvement initiatives including system enhancements, training reports, databases, and/or dashboards. Develop procedures, checklists, templates supporting submission quality and best practices Maintain regulatory systems, databases, and tracking tools to ensure accuracy, completeness, and data integrity of regulatory information Determine and discern detailed requirements on submissions deliverables, schedule and tracking of appendices and documents for small to mid-scale regulatory affairs projects Prepare and evaluate compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies Evaluate and interpret Tier 2 assessments impacting assigned BU (e.g., TMTT) Provide input on preparation of documentation packages, supporting team and company goals and objectives in order to interact effectively within the regulatory affairs team Prepare for regulatory agency inspections and audits (e.g., track RA plans and changes, understanding requirements) What you will need (Required): Bachelor's Degree and a minimum of 3 years related experience or equivalent work experience based on Edwards Coursework, seminars, and/or other formal government and/or trade association training What else we look for (Preferred) : Bachelor's Degree in scientific discipline (e.g., Biology, Microbiology, Chemistry) Experience preparing domestic and international product submissions Proven successful project management leadership skills Good written and verbal communication skills and interpersonal relationship skills Good problem-solving, organizational, analytical and critical thinking skills Solid knowledge and understanding of global regulatory requirements for new products or product changes Strict attention to detail Ability to interact professionally with all organizational levels Ability to manage competing priorities in a fast-paced environment Must be able to work in a team environment, including inter-departmental teams and representing the organization on specific projects 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, the base pay range for this position is $74,000 - $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. #LI-Hybrid Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.