Regulatory Affairs - Senior Manager

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 RA Manager Mexico will lead a team of RA experts with complex projects. This role will work collaboratively with the business to seek efficiencies in the current team's operation, challenge the team to look for alternative regulatory strategies and work hand in hand with the business as a whole. The manager will orient, mentor, and develop the team for professional growth and further business impact. In addition, this role will coordinate to position BSC as a key influencer in industry groups and drive positive change.

Required Qualifications

• Bachelor's degree.
• At least 5 years of management experience
• Minimum of 10 years of experience in regulatory affairs in medical devices or pharmaceutical industry.
• Expert knowledge of COFEPRIS regulations, guidelines, and requirements. Knowledge of other international regulatory requirements is a plus.
• Strong communication, organizational, and team management skills.
• Experience with management of complex teams.
• Ability to orient and mentor the professional development of their team.
• Ability to work in a fast-paced environment with changing priorities and tight timelines.
• Experience presenting business cases for projects and leading their execution.
• Experience leading and working collaboratively with cross-functional teams.
• Fully Bilingual (English, Spanish)

Preferred Qualifications

• Bachelor's degree in life sciences, engineering, or related field required; advanced degree preferred.
• Strong relationships with industry associations and evidence of influencing / leading regulation changes.

Key Responsibilities

• Participate and advocate with external industry groups to implement regulations that benefit the industry and public health.
• Develop and incentivize alternative regulatory strategies to benefit the business.
• Manage organizational structure for the process efficiency.
• Develop and implement plans for professional development of the team.
• Ensure regulatory strategies are implemented to maintain compliance with domestic and regional regulatory requirements.
• Advise cross-functional teams on regulatory requirements and assist with interpreting and implementing regulations.
• Manage the RA team to optimize the preparations of regulatory dossiers aligned with the commercial strategy.
• Ensure the team efficiently prepares for regulatory assessments for changes in existing products.
• 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!