Regulatory Affairs Specialist
4 tygodni temu
About the Role:
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Boston Scientific. As a key member of our regulatory team, you will be responsible for planning and prioritizing product notification/registration for various countries, preparing and submitting regulatory applications, and maintaining active knowledge of product approval status.
Key Responsibilities:
- Plan and prioritize product notification/registration for EU and non-EU countries
- Prepare and submit regulatory applications to local health authorities and/or distributors
- Maintain active knowledge of product approval status and shepherd registrations throughout the approval process
- Ensure product registrations are reviewed and renewed as required
- Establish and maintain a good working relationship with regional and divisional RA peers
- Establish and maintain a trusted relationship with local health authorities and/or distributors
- Serve as a regulatory consultant to marketing teams
Requirements:
- Self-starter with 2 years' experience in RA department
- Fluent written and spoken English
- Applicable regulatory certification required by NAMMDR would be an advantage
- Ability to manage multiple projects and data and strong attention to detail
- Ability to communicate effectively to all levels of organization and distributors/consultants
We Offer:
- Contract for 18 months
- Hybrid working mode
- Working in the international, innovative environment and highly innovative products
- Diverse culture with a focus on personal development and continuous improvement
- Well-designed & effective trainings plans
- Career opportunities like mentoring, coaching and stretch assignments, with strong international exposure
About Boston Scientific:
As a leader in medical science for more than 40 years, we are committed to solving the challenges that matter most – united by a deep caring for human life. Our mission to advance science for life is about transforming lives through innovative medical solutions that improve patient lives, create value for our customers, and support our employees and the communities in which we operate.
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