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Regulatory Specialist (12 months contract)
Symetis SA - Ecublens
19.08.2019 | Employé | 100%

Company:

Symetis SA, a Boston Scientific Company, develops and produces innovative, minimally invasive heart valve replacement devices. The company’s product ACURATE neo and delivery systems, based on proprietary design and delivery technologies, are marketed and sold in key markets in Europe and in other markets, and are well positioned to target the constantly growing TAVI market.

Purpose and Passion:

At Boston Scientific, you will find a collaborative culture driven by a passion for innovation that keeps us connected on the most essential level. With determination, imagination and a deep caring for human life, we’re solving some of the most important healthcare industry challenges. Together, we’re one global team committed to making a difference in people’s lives around the world. This is a place where you can find a career with meaningful purpose improving lives through your life’s work.

Regulatory Specialist

Role purpose:

Responsible for Regulatory Affairs support of the product development process, submissions, maintenance of regulatory files and regulatory compliance.

Tasks and Responsibilities:

  • Working as part of a team responsible for Regulatory Activities with specific responsibility for transcatheter heart valves.
  • Preparation and review of technical and process information for global submission activities as well as for change orders, working closely with R&D, DA and Operations groups.
  • Provide support to the core team on all aspects of regulatory strategy for the valve product(s) including development and execution of plans.
  • Review and approve documentation related to product release.
  • Provide input, review and approve facility regulatory activities
  • Provide updates on regulatory requirement changes, either on individual product specification or quality systems.
  • Understands and proactively follow through on the Environmental Management Procedures that have been identified as relevant to position.
  • Understand and implement the Product Lifecycle processes in particular sustaining activities.
  • Participates in Regulatory Body audits such as FDA, Notified Body.
     

Your profile (Experience, Skills, Education):

  • Bachelor’s in science/Engineering discipline or equivalent with minimum 1 years’ experience in a regulated environment.
  • Good interpersonal, communication and teamwork skills essential.
  • Previous experience within Regulatory Affairs would be an advantage.
  • Fluent in English, French is an asset.
     

Apply now:

In addition, for this exciting job we offer you an attractive compensation package, very good opportunities for personal and professional development through our established talent management program. Above all, you will have the opportunity to become part of a culture where everyone contributes to improving people's lives at all levels. Please let us know more about yourself by applying in English and clicking on the link below.

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