Regulatory Affairs Specialist

Additional Locations: Greece-Athens (Attica); Spain-Madrid

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.

This role is to support the Europe Middle East & Africa (EMEA) region in a regulatory affairs capacity. The team is dynamic and provides significant support to local in-country regulatory specialists among other departments. Within the Regulatory Affairs organization, the main objectives of the role will be to contribute to successful regional business goals by supporting day to day regulatory activities across the region. This includes indirect interaction with local regulatory authorities, a focus on regulatory support to cross-functional and divisional business units, regulatory operations, and regional advocacy efforts for the entire Boston Scientific product portfolio.

Key Responsibilities:

• Providing regulatory support to the Regulatory teams throughout EMEA (Europe Middle East and Africa) region and support of some cross-divisional activities.
• Assess product change notifications for impact to product registrations and notifications in the EMEA region.
• Registering and updating product data in Competent Authority databases
• Using, maintaining and developing digital and AI tools for information retrieval and database maintenance
• Maintaining the EMEA Regulatory database based on the information received from US Divisional Teams and from internal processes. Database contains regulatory information for all Boston Scientific Medical Devices.
• Tracking documentation changes via internal systems.
• Developing and maintaining a link for Divisional RA teams, communicating new products certifications and recertification’s.
• Establish and maintain a good working relationship with regional regulatory affairs, cross-functional peers and business units to gain positive & timely support.
• Supporting regulatory operations activities in conjunction with global regulatory operations.
• Suggest opportunities to add efficiencies to existing processes as part of department’s VIP goals.

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained in order to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Requirements:

• First experience in RA department
• Fluent written and spoken English
• Ability to manage multiple projects and data and strong attention to detail
• Ability to communicate effectively to all levels of organization and distributors/consultants
• Very good knowledge of MS Office
• Bachelor’s or master’s degree in pharmacy, biotechnology, chemistry or other related science or technical field

We offer:

• Work in an international environment with development opportunities
• Other benefits (depends on coutry specific)

Requisition ID: 598733

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!