Specialist, Regulatory Affairs TMTT

Edwards Lifesciences; Irvine (CA); On-site; USD 72,000 - 102,000; Full time

Job summary

Join a forward-thinking company dedicated to improving patient outcomes through innovative medical technologies. As part of the Regulatory Affairs team, you'll play a crucial role in guiding products through complex regulatory landscapes, ensuring compliance and facilitating timely submissions to global agencies. Your expertise will directly impact the approval of life-saving devices, making a meaningful difference in patients' lives. This is an exciting opportunity to contribute to a dynamic team focused on addressing unmet clinical needs and enhancing healthcare solutions.

Benefits

Competitive Salaries

Performance-Based Incentives

Diverse Benefits Programs

Qualifications

• 3+ years of experience in regulatory affairs with a focus on medical devices.
• Knowledge of global regulations for Class II and III devices.

Responsibilities

• Represent regulatory function in product development teams.
• Prepare documentation packages for global regulatory agencies.
• Monitor global regulations and assess their impact on projects.

Skills

Regulatory Affairs

Attention to Detail

Technical Mastery

Documentation Preparation

Regulatory Compliance

Education

Bachelor's Degree

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:

• Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving conflicts between those requirements and development issues, and/or reporting to management.
• Prepare and oversee documentation packages for submission to global regulatory agencies. Track timelines and document milestone achievements for inclusion in regulatory submissions. May interact with regulatory agencies as part of submission review and on-site audit support (e.g., IDEs, PMAs, annual reports, 510(k)s, STEDs and CE marking design dossiers and technical files).
• Provide guidance on regulatory requirements necessary for contingency planning.
• Monitor proposed and current global regulations and guidance; assess the impact of such regulations and guidance on assigned project(s); propose suggestions on utilizing regulatory updates to expedite the approval process.
• Review labeling content, product and process changes, and product documentation to assure regulatory requirements compliance, consistency, and accuracy.
• Prepare documents for submissions, including assuring the appropriate forms for all of the global regulatory bodies; assist with GUDID submissions.

What you will need (Required):

• Bachelor's Degree.
• A minimum of 3 years related experience.
• Coursework, seminars, and/or other formal government and/or trade association training.

What else we look for (Preferred):

• Solid knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices.
• Solid knowledge and understanding of global regulatory requirements for new products or product changes.
• Solid knowledge of new product development systems.

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 $72,000 to $102,000 (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.