Regulatory Affairs Specialist - Paris, France - Stryker Corporation

Stryker Corporation

Entreprise vérifiée

Paris, France

il y a 2 semaines

Posté par:

Sophie Dupont

beBee Recruiter

Description

We are looking at a Regulatory Affairs Specialist to join and complete our team.

You will be responsible for the coordination and preparation of document packages to secure timely approvals and maintain market clearance with a primary focus on EU + Turkey and/or other regions as assigned.

Key Areas of Responsibility (non-exhaustive list
):

Leads the execution and
delivery of the registration plan for EMEA, ensuring compliance with local regulatory requirements.
Prepares and
submits registration dossiers to Stryker EU sites** and distributors across assigned countries.

-
Follows up on registrations with Stryker EU sites and distributors.
-
Communicates with local authorities to obtain Registration Certificates/Import Licenses when necessary.
-
Monitors rules and regulations across EMEA, assessing their impact on import licenses and registrations.

Researches regulatory requirements and
options for submissions and approval pathways.
Provides regular feedback to the SNV Commercial & International RA team on project statuses.
Manages the release of registration holds, communicates decisions with customer service, commercial team, and distributors.

Your profile**:

-
Regulatory Affairs Experience: Over 2 years in medical device regulatory affairs
-
EU Regulations Expertise: Thorough understanding of EU medical device regulations and EMEA registration requirements
-
Research and Analysis Skills: Effective research and analytical capabilities, ability to analyze data and statistics and present to varied audiences
-
Detail Oriented** : Not afraid of repetitive work and reporting on databases
-
Project Management: Ability to manage multiple projects
-
Communication Skills: Strong written and oral communication, including technical writing

Ability to communicate effectively with EMEA / International RAQA and Commercial management teams

-
Autonomous Work: Can work independently with mínimal supervision
-
Leadership and Teamwork: Capable of leading complex projects, working in cross-cultural teams, and effective communication with stakeholders

Why join us?**- We've been voted the
8th best company in the world to work for in the medical field.
-
We develop talent:We give you the opportunity to develop your career according to your strengths. Stryker is a career destination for passionate, talented people who are looking for innovation, growth and the opportunities that only we can offer.

Flat hierarchies and responsibility: thanks to flat hierarchies, we reinforce the
spirit of initiative and the willingness of our employees to take on tasks of responsibility.
Team spirit and commitment: we create committed and
inclusive teams that encourage colleagues to share their diverse perspectives and opinions.

-
Competitive salary: with us, you'll enjoy competitive compensation, benefits and a pension plan.

**About Stryker