Senior Analyst, Project Management, Regulatory Affairs Surgical
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Job Location:
Irvine, CA - USA
Monthly Salary:
Not Disclosed
Posted on:
21 hours ago
Vacancies:
1 Vacancy
Job Summary
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:
- Lead the execution of tasks as defined in the project management plan and actively manage project risk. Determine and discern detailed requirements on mid-to-large scale projects to establish the project deliverables and develop the project management plan and manage changes to the project scope schedule and costs to keep the project management plan updated and reflective of authorized project changes. Determine and discern detailed requirements on submissions deliverables schedule and tracking of appendices and documents for mid-to-large regulatory affairs projects
- Lead various regulatory affairs improvement initiatives including submission standardization regulatory systems and standards management. Develop procedures checklists templates supporting submission quality and best practices
- Prepare for and provide guidance on regulatory agency inspections and audits (e.g. track ra plans and changes understanding requirements)
- Assess project performance to monitor the progress of the project identify and quantify variances perform required corrective actions and communicate to all stakeholders
- Establish and coordinate team members and stakeholder relationships expectations and communications
What youll need (Required):
- Bachelors Degree & a minimum of 5 years experience hands on experience managing mid-to-large scale projects OR equivalent based on Edwards criteria
What else we look for (Preferred):
- Project Management Professional (PMP)
- Certified Notary Public with active license authorized to verify and authenticate legal documents contracts and signatures to ensure compliance and accuracy
- Regulatory Affairs project management experience
- Excellent documentation and communication skills and interpersonal relationship skills including negotiating and relationship management skills with ability to drive achievement of objectives
- Substantial understanding and knowledge of principles theories and concepts relevant to managing small-to-mid-scale project plans
- Ability to adapt to rapidly changing environment
- Strong problem-solving organizational analytical and critical thinking skills
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 $90000 to $127000 (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.
Required Experience:
Senior IC
Key Skills
- Proofreading
- Adobe Acrobat
- FDA Regulations
- Manufacturing & Controls
- Biotechnology
- Clinical Trials
- Research & Development
- GLP
- cGMP
- Product Development
- Chemistry
- Writing Skills
About Company
Edwards Lifesciences (NYSE: EW), is the global leader of patient-focused medical innovations for structural heart disease and critical care monitoring. We are driven by a passion for patients, dedicated to improving and enhancing lives through partnerships with clinicians and stakehol ... View more
