Senior Rep, Labeling

Innovation starts from the heart. Edwards Lifesciences is the global leader of patient-focused innovations for structural heart disease and critical care monitoring. With millions of patients served in over 100 countries, each team makes a meaningful contribution by improving patient outcomes and discovering lasting solutions for unmet patient needs. The Sr. Labeling Rep position is a unique career opportunity that could be your next step towards an exciting future.

The Sr. Labeling Rep partners with labeling and business cross-functional project teams to implement labeling solutions for label and IFU creation and release. This role will be accountable for ensuring that all work associated with updates or changes to global labeling standards/procedures, training plans and process improvements, routing and approval of assigned labeling deliverables through ECR and PDM processes is carried out in compliance with relevant standards and regulations.
How you’ll make an impact:
• Execute complex label change packages (e.g., ECO, mass updates, redlines, ECR generation and processing, compiling documentation, data entry) within and across all business units/sites with limited to no direction. Summarize and capture change intent accurately within quality system (e.g., ECR) in adherence to GDP (Good Documentation Practices). Actively follow up on change requests (e.g., SARS, ECRs) and manage approvers to ensure timely closure
• Evaluate routine risks and provide recommendations to resolve issues.
• Update more complex procedures and lead routine process improvement opportunities within scope
• Provide training and coaching to other team members
• Other incidental duties
What you’ll need (minimum qualifications):
• H.S. Diploma or equivalent and 6 years of related work experience OR
• Associate's Degree or equivalent and 4 years of related work experience

What else we look for (preferred skills):
• Previous experience working in a medical/pharmaceutical FDA regulated industry

• Good computer skills including usage of MS Office Suite, design software experience is a plus
• Excellent written and verbal communication skills and interpersonal relationship skills
• Able to build stable working relationships internally
• Able to read, comprehend, write, and speak English

• Good time management and organizational skills
• Basic understanding of domestic development and implementation of labeling

• Basic understanding of medical and/or pharmaceutical regulations and standards

• Basic knowledge of medical device documentation development activities

• Knowledge of Change Control processes

• Basic problem-solving, organizational, analytical and critical thinking skills

• Strict attention to detail

• Work is performed independently on sections of projects and/or lines of work and reviewed for accuracy and soundness

• Participates in arranging own activities in accomplishing objectives
• Full knowledge and understanding of policies, procedures, and requirements as it relates to task execution within labeling operations

• Full knowledge of labeling systems and applications (e.g., ECR and PDM processes)
• Must be able to work in a team environment, including inter-departmental teams and other business units, under general supervision
• Contributes to the completion of sections of organizational projects and goals
• Participate and lead process improvement activities

• Adhere to all company rules and requirements (e.g., pandemic protocols, Environmental Health & Safety rules) and take adequate control measures in preventing injuries to themselves and others as well as to the protection of environment and prevention of pollution under their span of influence/control
 

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 $50,000 to $68,000 (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.   

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.