Associate Specialist, Regulatory Affairs Operations TMTT

Edwards; California (MO); Hybrid; USD 59,000 - 83,000; Full time

Job summary

Edwards is seeking a Regulatory Affairs professional to guide medical device submissions across global regulatory environments. You will partner with external authorities and internal teams to ensure compliance and timely submissions.

The role emphasizes coordination of deliverables, documentation preparation, and readiness for inspections. California base pay is specified, with a hybrid work model and opportunities to influence process improvements.

Qualifications

• 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.

Responsibilities

• 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).

Skills

Regulatory knowledge

Project management

Communication skills

Regulatory writing

Education

Bachelor's degree

Science background

Tools

Microsoft Office Suite

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 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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