Associate Specialist, Regulatory Affairs Operations (Surgical)

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.

Dedicated to innovation our Surgical business unit is focused on identifying and solving critical unmet needs in cardiac understanding the challenges of open-heart surgery we partner with surgical teams to deliver modern technologies intended to enhance patients quality of life and expand their potential treatment opportunities. Its our driving force to help patients live longer and healthier lives. Join us and be part of our inspiring journey.

How youll 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
• 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 youll need (Required):

• Bachelors Degree and a minimum of 1 year related work experience or work experience based Edwards criteria
• Coursework seminars and/or other formal government and/or trade association training
  

What else we look for (Preferred):

• Bachelors Degree in a scientific discipline
• 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
• Good knowledge of new product development systems
• Proven successful project management skills
• Strong written & verbal communication skills
• Ability to work in a fast-paced environment
• Ability to develop cross-functional relationships

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 (CA) the base pay range for this position is $59000 to $83000 (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.

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities.

COVID Vaccination Requirement

Edwards is committed to protecting our vulnerable patients and the healthcare providers who are treating them. As such all patient-facing and in-hospital positions require COVID-19 vaccination. If hired into a covered role as a condition of employment you will be required to submit proof that you have been vaccinated for COVID-19 unless you request and are granted a medical or religious accommodation for exemption from the vaccination requirement. This vaccination requirement does not apply in locations where it is prohibited by law to impose vaccination.