Regulatory Affairs Specialist
Il y a 6 mois
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
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