- As a Senior Regulatory Affairs Specialist, you will partner with global cross-functional teams to provide input on requirements, strategies and documentation needed to obtain regulatory approval for clinical investigations in EMEA.
- You will prepare and submit the application files for clinical investigation to Competent Authorities.
- You will maintain regulatory files and tracking databases as required and communicate with regulatory agencies as needed.
- You will participate in team meetings with colleagues based in the US, EU, and other regions teams contributing to and learning from global clinical investigation submission and strategy experiences.
- You will support analysing and optimizing RA processes together with cross functional partners such as Quality Management, Clinical Affairs and Medical Safety in order to improve procedures or integrate new and changing regulations.
- You will also support the Regulatory Affairs team and other functions with internal and external audits.
- Advocacy / monitoring new regulations.
- You have completed BS in Engineering, Science, or related degree, or MS in Regulatory Science.
- You have gained a minimum of 4 years' experience in medical technology or another regulated sector in the area of quality, regulatory affairs or R&D.
- You have already acquired a working knowledge of ISO 14155, EU MDR 2017/745, MDCG and /1, and other national or global regulations related to clinical investigations.
- You have strong time management, coordination, and communication skills, capable of independently execute regulatory tasks& relevant administrative activities and demonstrating a proactive approach to work within a dynamic regulatory environment.
- Your English language skills enable you to collaborate with colleagues as well as internal and external stakeholders on a global basis. Additional language skills are an advantage.
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Senior Regulatory Specialist, EMEA Regulatory Affairs - Warsaw, Polska - Boston Scientific
Opis
Additional Locations:
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
Senior Regulatory Specialist, EMEA Regulatory Affairs (Clinical Investigation Support)
Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.
Diversity - Innovation - Caring - Global Collaboration - Winning Spirit - High Performance
At Boston Scientific, we'll give you the opportunity to harness all that's within you by working in teams of diverse and high-performing employees, tackling some of the most important health industry challenges. With access to the latest tools, information and training, we'll help you in advancing your skills and career. Here, you'll be supported in progressing – whatever your ambitions.
Team Purpose: The EMEA Regulatory Affairs team is a strategic partner that supports, delivers, and sustains business and regulatory solutions for customers.
This is a key role supporting clinical investigations in the EMEA region for the entire Boston Scientific product portfolio, reporting to the responsible Manager. Within the EMEA Regulatory Affairs organization, the main objectives of the role will be to contribute to successful business goals by supporting regulatory activities linked to pre- and post-market clinical investigations, as well as all associated safety reporting in the EMEA region.
Key Responsibilities:
Required Qualifications
Requisition ID: 581413
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. Now more than ever, we have a responsibility to apply those values to everything we do – as a global business and as a global corporate citizen.
So, choosing a career with Boston Scientific (NYSE: BSX) isn't just business, it's personal. And if you're a natural problem-solver with the imagination, determination, and spirit to make a meaningful difference to people worldwide, we encourage you to apply and look forward to connecting with you
