Regulatory Affairs Specialist

Additional Locations: Italy-Milan; 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.

About the role:

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.

Responsibilities:

• Providing regulatory support to the Regulatory teams throughout EMEA (Europe Middle East and Africa) region and support of some cross-divisional activities.
• Maintaining the 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 the documentation changes via internal systems.
• Developing and maintaining a link for Divisional RA teams, communicating new products certifications and recertification’s.
• Assess product change notifications for impact to the regulatory database in a timely manner.
• Establish and maintain a good working relationship with regional Regulatory Affairs, cross-functional peers and business units to gain positive & timely support.
• Supporting tender operations by timely supply of accurate regulatory documents.
• Supporting regulatory operations activities in conjunction with global regulatory operations.
• Support global advocacy efforts in monitoring regulation changes across the region.
• Suggest opportunities to add efficiencies to existing processes as part of department’s VIP goals.

Requirements:

• Bachelor's degree in a relevant subject (Science, Law or Communication).
• Fluent English (both writing and speaking).
• Standard computer skills (including MS Office).
• Experience in Regulatory Affairs or Medical Company is welcome but is not a must.
• Knowledge of the medical device regulation or quality systems will be advantageous.
• Ability to work under pressure and prioritize work.
• Ability to work both independently and in a team.
• Excellent organization of own work.
• Conscientious, details oriented & accurate.
• Fast learner.

We offer:

• Work in international environment with a global leader.
• Attractive employment conditions.
• Benefits: life insurance, private healthcare, sport card, launch card, Employee Assistance Program, parental policy, Employee Stock Purchase Plan, bonuses.
• Trainings and language courses.
   

Requisition ID: 578954

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!