Senior Specialist, Regulatory Affairs – Transcathether Mitral and Tricuspid Therapies

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

Job Description:

This is an exciting opportunity for an exceptional Regulatory Affairs professional to join a team that is boldly designing transcatheter mitral and tricuspid therapies from the ground up. TMTT is dedicated to solving the complex challenges of mitral and tricuspid disease in order to transform treatment and significantly improve patients’ lives.

The Senior Specialist, Regulatory Affairs for TMTT will complete and maintain clinical and commercial regulatory approvals of Class III implantable products in the US, Canada and EU, focused specifically on the paradigm shifting transcatheter valve replacement therapies.

Key Responsibilities: Represent the regulatory function on manufacturing and product development teams to provide input on regulatory requirements, including presenting alternatives for meeting regulatory requirements and resolving moderately complex conflicts between those requirements and development issues; also keeps management apprised of alternative actions.

Review and approve protocols, reports, engineering drawings, procedures, and other product development and manufacturing documentation to ensure regulatory requirements compliance, consistency, and accuracy.

Provide guidance on regulatory requirements necessary for strategic and contingency planning, including developing the preliminary regulatory strategic plans

Prepare and oversee documentation packages for submission to global regulatory agencies. Assist with GUDID submissions. Track timelines and documents milestone achievements for inclusion in regulatory submissions.

May interact with regulatory agencies as part of submission review and on-site audit support. (e.g., IDE’s, PMA’s, annual reports, 510(k)’s, STED’s and CE marking design dossiers and technical files)

Monitor proposed and current global regulations and guidance; assess impact of such regulations and guidance on assigned project(s), propose suggestions on utilizing regulatory updates to expedite approval process

Review labeling content product and process changes, and product documentation to assure regulatory requirements compliance, 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.

Coursework, seminars, and/or other formal government and/or trade association training is required

Experience preparing domestic and international product submissions for medical device products is preferred

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

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

Full knowledge and understanding of global regulations relevant to medical devices, Class II and/or Class III devices

Full knowledge and understanding of global regulatory requirements for new products or product changes.

Full knowledge of new product development systems

Good leadership skills and ability to influence change

Strict attention to detail

Ability to interact professionally with all organizational levels

Ability to manage competing priorities in a fast paced environment

Must be able to work in a team environment, including inter-departmental teams and key contact representing the organization on contracts or projects

Ability to interact with senior internal and external personnel on significant matters often requiring coordination between organizations

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 – Transcathether Mitral and Tricuspid Therapies, Other , Irvine, California