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Regulatory Affairs - Senior Manager

Work mode:  Hybrid
Onsite Location(s): 

Benito Juárez, DF, CMX, MX

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.

At Boston Scientific, we want you to bring your unique strengths to our team. We are committed to empowering women, supporting the LGBTQ+ community, and creating opportunities for individuals with disabilities. We believe that your diversity is our strength, and we are committed to fostering an environment where you can not only thrive but also bring your authentic self to work. As an equal opportunity employer, we wholeheartedly welcome applications from all qualified candidates, regardless of who you are or where you come from.

Purpose Statement

The role is critical in linking with the executive management team for the country and in the relationships with the competent authorities/health authorities.  Develops and manages a strong relationship with the competent authorities (covering product notifications, field actions, and any other specific program).  Provides regulatory support and expertise to the local organizations.  Manages the impact of the regional and national regulations on the business.  Supports lobbying activities.

What we are looking for in you

  • Bachelor's degree in life sciences, engineering or related field required; advanced degree preferred.
  • Minimum of 8 years of experience in regulatory affairs in the biotech, or pharmaceutical industry.
  • Expert knowledge of COFEPRIS regulations, guidelines, and requirements. Knowledge of other international regulatory requirements is a plus.
  • Strong communication, organizational, and project management skills.
  • Ability to work in a fast-paced environment with changing priorities and tight timelines.
  • Experience in medical device regulations is preferred.
  • Ability to lead and work collaboratively with cross-functional teams.

Key Responsibilities

  • Develop and implement regulatory strategies to ensure compliance with domestic and regional regulatory requirements.
  • Advise cross-functional teams on regulatory requirements and assist with the interpretation and implementation of regulations.
  • Manage the RA team to prepare and submit regulatory documentation aligned with the commercial strategy.
  • Prepare regulatory assessments for changes in existing products.
  • Develop and maintain registration and compliance records.
  • Maintain awareness of changes in regulatory requirements and industry trends that could impact the organization.
  • Build strong relationships and advocacy with regulatory authorities and participate in meetings and negotiations.

 

 

Requisition ID: 579023

 

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, Pharmaceutical, Compliance, Medical Device, Project Manager, Legal, Science, Healthcare, Technology

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