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Senior Specialist, Regulatory Affairs - Surgical Structural Heart

Company: Edwards Lifesciences
Location: Irvine
Posted on: October 15, 2020

Job Description:

For 60 years, the Edwards Lifesciences Surgical Heart Valve Therapy business has been committed to fostering surgical innovation through collaboration with clinicians. Today, with our surgeon partners, we continue to deliver innovations that empower surgeons to improve patient outcomes and enhance lives. This is an exciting opportunity to join a team that is continuing to advance the gold-standard products on which Edwards was founded, and to transform the surgical structural heart space with breakthrough innovations to advance patient care.

The Senior Specialist, Regulatory Affairs is responsible for activities within the respective country(is). Key responsibilities include: 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.

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

Other incidental duties

Education and Experience: A Bachelor’s degree in a related field is required; a scientific discipline is preferred.

A minimum of five years of related experience is required with a Bachelor’s degree, OR, a minimum of three years of related experience is required with a Master’s degree.

Experience in preparing domestic and international product submissions in medical device is required

Additional Skills: Proven expertise in Microsoft Office Suite including Word, PowerPoint and Excel

Excellent written and verbal communication skills including negotiating and relationship management skills with ability to drive achievement of objectives

Excellent problem-solving, organizational, analytical and critical thinking skills

Recognized as an expert in own area with specialized depth within the organization

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

Strong leadership skills and ability to influence change

Strict attention to detail

Ability to interact professionally with all organizational levels and proactively escalate issues to appropriate levels of management in the organization

Ability to manage competing priorities in a fast paced environment

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

Adhere to all EHS rules and requirements 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

Edwards is an Equal Opportunity/Affirmative Action employer including protected Veterans and individuals with disabilities. SDL2017

Keywords: Edwards Lifesciences, Irvine , Senior Specialist, Regulatory Affairs - Surgical Structural Heart, Other , Irvine, California

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