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Regulatory Affairs Specialist, SEE

Work mode:  Hybrid
Onsite Location(s): 

Bucharest, RO

Additional Locations:  N/A

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.

Regulatory Affairs Specialist - Maternity Cover (2 Years)

 

As a Regulatory Affairs Specialist you will act as the person responsible for regulatory compliance for Boston Scientific Romania, as required by the Romanian Medical Devices Agency NAMMDR.

 

This position is an Maternity Cover and will be 2 Years contracted.

 

Key responsibilities:

  • Plan and prioritize product notification/registration for his/her respective countries (EU and non-EU)
  • 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. Provide management team with regular updates on product registration
  • Ensure product registrations are reviewed and renewed as required
  • Ensure documentation used, questions and answers from authorities and approvals are appropriately filed
  • Be the first contact point for local authorities for regulatory queries
  • Establish and maintain a good working relationship with regional and divisional RA peers to gain positive and timely support for submission preparation
  • Establish and maintain a trusted relationship with local health authorities and/or distributors through regular meetings, discussions and/or trainings
  • Establish relationships with local medical device industry groups and work with industry peers to influence local policies
  • Support tender operations by timely supply of accurate regulatory documents
  • Serve as a regulatory consultant to marketing teams
  • Complete the mandatory Quality training subject to the defined timeline and ensure compliance with internal Quality system and policy.

 

 Requirements:

  • Self-starter with 2 years experience in RA department
  • Fluent written and spoken English and Romanian (knowledge of Ukrainian would be an advantage)
  • 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
  • Very good knowledge of MS Office
  • Bachelor’s or Master's degree in pharmacy, biotechnology, chemistry or other related science or technical field

 

Requisition ID: 575930

 

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!


Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, Pharmacy, Legal, Healthcare

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