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Manager, Regulatory Affairs Operations - Critical Care

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

Job Description:

This is an outstanding opportunity to be a part of a forward-thinking regulatory affairs organization. The Manager, Regulatory Affairs will focus on supporting projects for our critical care sustaining products. We are looking for a diligent RA professional who works well across functional teams, takes initiative, and enjoys working in a fast-paced team environment.

Key Responsibilities: Manage and oversee the work of team within country regulatory affairs and may indirectly manage cross functional or matrix teams as appropriate. Develop a robust talent development plan in alignment with functional growth strategies of the department

Manage activities with the accountability for successful completion of all deliverables. Plan registration, labeling, pricing and reimbursement activities within agreed timeline in order to deliver licenses and to ensure regulatory compliance and market access

Develop in-country annual strategy on new product introduction pipeline and R&D budget forecast and management

Identify risk, develop and lead in the implementation of registration and labeling strategies which may include negotiations with internal and external parties

Other incidental duties

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

A minimum of ten years of related experience is required with a Bachelor’s degree, OR, a minimum of eight years of related experience is required with a Master’s degree

A demonstrated track record in people management is required

Experience working in the medical device industry is required

Additional Skills: Proven successful project management leadership skills

Proven expertise in both Microsoft Office Suite and government regulatory systems

Excellent problem-solving, organizational, analytical and critical thinking skills including high discretion/judgment in decision making

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

Good presentation skills

Excellent English skills

Expert understanding of regulatory affairs procedures while addressing issues with impact beyond own team based on knowledge of related disciplines

Expert understanding of related aspects of product lifecycle processes and Edwards Ignite system and government regulatory systems

Knowledge of global cross functional teams and how to interact e.g. labeling business units, marketing, regulatory affairs, quality functions

Knowledge of financial mechanism that relates to budget forecast and profit & loss

Demonstrated ability to manage assigned team and provide coaching and feedback, including responsibility for all employee actions including hire/fire authority and partnering with HR on all aspects of employee relations

Ability to develop and integrate metrics into the projects and operations that clearly demonstrate the value of regulatory affairs to the business

Extensive knowledge of Edwards products

Knowledge of healthcare industry

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 work and excel within a fast paced, dynamic, and constantly changing work environment

Frequently interacts with customers, and/or functional peer group managers, normally involving matters between functional areas, other company divisions or units, or customers and the company; often leads a cooperative effort among members of a project team

Participate and present at meetings with internal and external representatives

Resolve operational and scheduling issues

Dedicated to quality client service and pro-active and responsive to client needs.

Develop peer, cross functional and cross business relationships to maximize best practice sharing and team effectiveness.

Develop relationships and leverage them to influence change

Support and solicit input from team members at all levels within the organization

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 , Manager, Regulatory Affairs Operations - Critical Care, Other , Irvine, California

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