Associate Specialist, Regulatory Affairs Operations TMTT

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

Job summary

Edwards Lifesciences is seeking a Regulatory Affairs professional to support process improvements, coordinate global submissions, and maintain regulatory records. The role involves collaboration with cross-functional teams to ensure timely and compliant documentation for regulatory approvals.

The ideal candidate will have a science degree, experience in regulated industries, and strong project management and communication skills.

Qualifications

• Bachelor's Degree or equivalent work experience based on Edwards criteria.
• Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent experience.
• Experience in a regulated industry and strong project management skills.

Responsibilities

• Develop routine Regulatory Affairs process improvements including system enhancements, training reports, and dashboards.
• Coordinate submissions deliverables, schedule and tracking of appendices and documents.
• Prepare compilation and publication of paper and electronic documentation for regulatory submissions.
• Maintain regulatory records and submission documentation in accordance with procedures.
• Prepare for regulatory inspections and audits and track RA plans and changes.

Skills

Attention to detail

Communication skills

Project management

Regulatory knowledge

MS Office skills

Education

Bachelor's degree or equivalent

Bachelor's degree in science

Tools

MS Office

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 dashboardsExecute the coordination of submissions deliverables, schedule and tracking of appendices and documentsPrepare compilation and publication of paper and electronic documentation packages for submission to global regulatory agencies in collaboration with team membersSupport management, retrieval, archival, and maintenance of regulatory records and submission documentation in accordance with applicable procedures and regulatory requirementsMaintain regulatory systems, databases, and tracking tools to ensure accuracy, completeness, and data integrity of regulatory informationReview and/or interpret standard assessments to ensure product complianceInteract effectively within the regulatory affairs team in the preparation of documentation packages, supporting team and company goals and objectivesPrepare 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 criteriaCoursework, seminars, and/or other formal government and/or trade association training or equivalent work experience based on Edwards criteriaWhat else we look for (Preferred) :Bachelor's Degree in a scientific discipline (e.g., Biology, Microbiology, Chemistry) or equivalent work experience based on Edwards criteriaExperience working in a regulated industryProven successful project management leadership skillsProven expertise in Microsoft Office Suite and related tools and systemsExcellent written and verbal communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectivesAbility to develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectivenessStrict attention to detailAbility to work and excel within a fast paced, dynamic, and constantly changing work environmentGood 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 changesAligning 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.#LI-HybridEdwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.