Associate Specialist, Regulatory Affairs Operations TMTT

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 routine Regulatory Affairs process improvement initiatives including system enhancements, training reports, and/or dashboards

Execute the coordination of submissions deliverables, schedule and tracking of appendices and documents

Prepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies in collaboration with team members

Support management, retrieval, archival, and maintenance of regulatory records and submission documentation in accordance with applicable procedures and regulatory requirements

Maintain regulatory systems, databases, and tracking tools to ensure accuracy, completeness, and data integrity of regulatory information

Review and/or interpret standard assessments to ensure product compliance

Interact effectively within the regulatory affairs team in the preparation of documentation packages, supporting team and company goals and objectives

Prepare for regulatory agency inspections and audits (e.g., track RA plans and changes, understanding requirements)

What you will need (Required):

Bachelor's Degree or equivalent work experience based on Edwards criteria

Coursework, seminars, and/or other formal government and/or trade association training or equivalent work experience based on Edwards criteria

What else we look for (Preferred):

Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent work experience based on Edwards criteria

Experience working in a regulated industry

Proven successful project management leadership skills

Proven expertise in Microsoft Office Suite and related tools and systems

Excellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives

Ability to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness

Strict attention to detail

Ability to work and excel within a fast paced, dynamic, and constantly changing work environment

Good knowledge and understanding of global regulations relevant to medical devices (e.g., Class I, Class II and/or Class III devices)

Good knowledge and understanding of global regulatory requirements for new products or product changes

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 $59,000 - $83,000 (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.

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