Regulatory Affairs Engineer - Montpellier, France - Zimmer Biomet

Zimmer Biomet

Entreprise vérifiée

Montpellier, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

Requisition Number:
EMEA09756

Employment Type:
Full-time

Location:
Montpellier

What Is It Like To Work at Zimmer Biomet:
At
Zimmer Biomet, we believe in
The Power of Us, which means that we are stronger together. We are committed to creating an environment where every team member feels included, respected, empowered, and celebrated.

Zimmer Biomet Offers You An Exciting Position With Good Career Prospects in a Fast-growing International Business, And a Competitive Remuneration Package

Possibility to grow, develop, and be promoted within a Team
Friendly, warm and creative atmosphere
Healthy, inspiring, and international work environment
Ongoing coaching and talent development
Access to future career opportunities
Hybrid work model
Competitive reward packages
Annual bonus
Social and CSR events
Wellbeing initiatives

What You Can Expect:

Reporting to the Group Regulatory Affairs Director and working closely with other team members and departments, the Regulatory Affairs Engineer will implement the necessary actions to ensure the site's compliance with NF EN ISO 13485, CFR 21 Part 820, 806, Sors 98-282, Directive 93/42/EEC (amended by Directive 2007/47/EC), MDR 2017/745, CFDA and any other standards deemed necessary for the company's development.

How You Create Impact:

Respect the Group's values
Ensure product compliance with the standards applicable in the markets where the product is sold
To manage the processes for the marketing of devices, registrations and their maintenance
Manage product registration processes in the different countries and ensure their renewal according to commercial needs
Review proposed product changes to assess their impact on the regulatory status of products and ensure continued compliance with applicable standards
Organize regulatory monitoring
Manage the process of reporting changes to the relevant bodies
Maintain the technical file for CE marking and the design history file in conjunction with the R&D and production departments
Participate in the marketing/regulatory strategy for the planning of the product launch

What Will Make You Stand Out:

The Regulatory Affairs Engineer has an engineering background or equivalent university education. Prior to joining the company, the Regulatory Affairs Engineer may have experience in implementing and leading Quality Management Systems in the medical device industry or in a highly regulated environment.
Several years of professional experience in a Quality / Control operational function in the medical device industry or other regulated environment

What Will Make You Successful:

Knowledge of DM ISO 13485, DM 93/42, GMP, FDA
Knowledge of the , 62304 standard
Practice of audit techniques
Good written and oral communication
Diplomacy and contact skills
Professional written and spoken English
General knowledge of the main technologies (software, mechanical) applied to medical devices
Indepth knowledge of quality tools and methods
Critical thinking, listening skills, good analytical skills and strong qualities of rigour and method.
Ability to impose the applicable procedures in force, and to demonstrate a certain pedagogical sense

Who We Are:

Zimmer Biomet is a world leader in musculoskeletal health solutions. Our team members are part of a company with a heritage of leadership, a focus on shaping the future, and a mission dedicated to _alleviating pain and improving the quality of life for people around the world_.