Senior Manager, Regulatory Affairs TMTT job opportunity at Edwards Lifesciences Corporation.

Home Jobs In United States Of America Tag: Regulatory Affairs TMTT Senior Manager, Regulatory Affairs TMTT position at Edwards Lifesciences Corporation


DatePosted 14 Days Ago bot
Edwards Lifesciences Corporation Senior Manager, Regulatory Affairs TMTT
Experience: 10-years
Pattern: full-time
Country:
apply Apply Now
Salary:
Status:

Regulatory Affairs TMTT

Copy Link Report
degreeOND
loacation USA - California – Irvine, United States Of America
loacation USA - Californ..........United States Of America

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: Manage rest of world (all geographies outside the US & EU).  Develop and plan multiple regulatory affairs projects and activities including analysis of situations or data requiring an evaluation of intangible variables with accountability for successful completion of all project deliverables. Includes representing the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including providing alternatives for meeting regulatory requirements and resolving complex conflicts between those requirements and development issues. Review and approve protocols, reports, engineering drawings, procedures, labeling and other product development and manufacturing documentation to ensure compliance with regulatory requirements, consistency and accuracy Partner with regional regulatory affairs teams to develop strategies, define requirements and execute on rest of world submissions. Identify and evaluate regulatory affairs process improvement and/or course correction/course alignment opportunities to accelerate route to market access in collaboration with key stakeholders Provide direction and guidance to project teams to execute tactical regulatory affairs projects and/or initiatives. Includes preparation and oversight of larger documentation packages for submission to regulatory agencies. Track timelines and documents for inclusion in regulatory submissions. Interact with regulatory agencies as part of submission review and on-site audit support Develop strategies and contingency plans for projects, including those that are most complex and challenging May anticipate and advise on future regulatory trends and direction, and recommend preemptive approaches for company regulatory compliance May act as a key member in RA committee (e.g., AdvaMed, standards/committee) and provide input on the development of standards/regulations that affect the Medical Device industry May review promotional material and labeling content to ensure compliance with regulatory requirements, consistency and accuracy What you will need (Required): Bachelor's Degree and a minimum of 10 years related experience or equivalent work experience based on Edwards criteria Demonstrated track record of people management Experience working in a medical device, pharmaceutical or RA company Ability to travel up to 30% internationally What else we look for (Preferred) : Master's Degree and a minimum of 8 years related experience or equivalent work experience based on Edwards criteria Expert knowledge and understanding of global regulations relevant to Class II and/or Class III medical devices Expert knowledge and understanding of global regulatory requirements for new products or product changes Expert knowledge of new product development systems Represents leadership on projects within a specific area interfacing with project managers and regulatory affairs team Consult in project setting within specific regulatory affairs area Provides regulatory affairs leadership to outsourcing partners on a task level, and may participate on small scale RFP Proven successful project management leadership skills Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines 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 $145,000 to $205,000 (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. E dwards 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.

Other Ai Matches

Manager, Test Automation Engineering Applicants are expected to have a solid experience in handling Test Automation Engineering related tasks
Senior Manager, Finance Applicants are expected to have a solid experience in handling Finance related tasks
Associate Machine Operator Applicants are expected to have a solid experience in handling Job related tasks
Field Clinical Specialist TMTT (Based in Minas Gerais, Goiânia or Brasilia) Applicants are expected to have a solid experience in handling Goiânia or Brasilia) related tasks
Technician, Laboratory (18 Months Contract) Applicants are expected to have a solid experience in handling Laboratory (18 Months Contract) related tasks
Sales Operations Analyst, BD Advanced Patient Monitoring Applicants are expected to have a solid experience in handling BD Advanced Patient Monitoring related tasks
Senior Specialist, Talent Acquisition, APAC Applicants are expected to have a solid experience in handling Talent Acquisition, APAC related tasks
Clinical Specialist, THV, 福岡 Applicants are expected to have a solid experience in handling THV, 福岡 related tasks
Intern, Business Solutions Applicants are expected to have a solid experience in handling Business Solutions related tasks
Second Shift Associate Inspector (THV) Applicants are expected to have a solid experience in handling Job related tasks
Smart Factory Solutions Architect Applicants are expected to have a solid experience in handling Job related tasks
Principal R&D Mechanical Engineer Applicants are expected to have a solid experience in handling Job related tasks
Manager, Professional Education, BD Advanced Patient Monitoring Applicants are expected to have a solid experience in handling Professional Education, BD Advanced Patient Monitoring related tasks
2nd Shift Associate Production Supply Applicants are expected to have a solid experience in handling Job related tasks
Senior Engineer, Software Quality Applicants are expected to have a solid experience in handling Software Quality related tasks
Working Student Sales Administration Applicants are expected to have a solid experience in handling Job related tasks
Senior Analyst, Strategy and Business Operations Applicants are expected to have a solid experience in handling Strategy and Business Operations related tasks
remote-jobserver Remote
Senior Product Manager, Transcatheter Mitral & Tricuspid Therapies Applicants are expected to have a solid experience in handling Transcatheter Mitral & Tricuspid Therapies related tasks
Senior Analyst, Finance (Cost Accounting) Applicants are expected to have a solid experience in handling Finance (Cost Accounting) related tasks
Manager, Product Marketing, TMTT Applicants are expected to have a solid experience in handling Product Marketing, TMTT related tasks
Manager, Engineering Applicants are expected to have a solid experience in handling Engineering related tasks
Sr Anaplan Developer, IT - Pune Applicants are expected to have a solid experience in handling IT - Pune related tasks
Business Unit Director TMTT Applicants are expected to have a solid experience in handling Job related tasks