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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.

Boston Scientific is a diverse company that is committed to empowering women, the LGBTQ+ community, and people with disabilities. We believe that diversity is a strength, and we are dedicated to creating an inclusive environment where all employees can thrive. We are proud to be an equal opportunity employer, and we welcome applications from all qualified candidates regardless of their background or identity.

What we are looking for in you

Career: Pharmaceutical, Chemical, Biotechnology, Biomedical or related.

Experience: 1 to 3 years of experience executing regulatory affairs activities in any health-related (Medical devices preferred) company

Activities and Skills Required for this Role:

• Execution and Initiative driven individual, highly analytical.
• Strong communication skills.
• Ability to think strategically and innovatively.
• Learning agility and emotional intelligence to adapt and respect cultural differences.
• Proven leadership skills to motivate and influence teams that do not report directly into the role.
• High proficiency of English language B1/B2 level.

• This role focuses on regulatory support, with a wide variety of regulatory tasks.
• Will have primary RA responsibility for multiple RA processes such as assessment of advertisement materials to approve those for marketing purposes.
• New Registrations of Class II and/or Class III products and maintain the approval and the actions through the medical device lifecycle, working within a collaborative team.
• Be responsible for the renewal process of the licenses approved and review with the commercial team the interest in maintaining the products on the portfolio.
• Update all databases from the regulatory Lifecycle such as, timeline metrics, submission, renewals, verification checklists, legal documents, tenders information , payments to COFEPRIS, etc.
• Knowledge about the local regulations (policies) in health and the medical device industry (NOM 241, NOM 240, NOM 137) also the general knowledge about international regulations organism as FDA, Health Canada and EU MDR will be appreciated.
• Participate in the Regulatory Working Groups from the different associations such as AMID, CANIFARMA, AMCHAM, IACRC, etc.
• Have an agile mindset and look for opportunities and strategies to improve the processes, generating savings in cost and time.
• Evaluate Regulatory Compliance: Thoroughly assess relevant regulations and guidelines pertaining to the advertising of medical devices, considering requirements for both the public and healthcare professionals. Ensure that advertising materials meet regulatory standards.
• Submission of Regulatory Documents: Prepare and submit regulatory dossiers necessary for obtaining approval of medical device advertising materials. This includes generating technical documentation, gathering supporting data, and effectively communicating with regulatory authorities.
• Data-Driven Decision Making: Utilize data and information to evaluate the effectiveness and compliance of medical device advertising materials. Analyze and interpret available data to inform evidence-based decision-making concerning regulatory aspects of advertising.
• Communication with Internal and External Clients: Effectively communicate with internal teams and external stakeholders, including clients and regulatory authorities. Provide guidance on regulatory requirements, address inquiries, and provide regular updates on the progress of regulatory submissions.
• Coordinate regulatory documentation activities and maintain data in information systems or databases. Direct contact with the Global RA specialist to get the legal documentation required for new products.
• Provide technical information of the products as COAs, DHR, CFGs, ISO certificates, etc.. requested by customers or by the tender's teams.
• Create and execute timely manner the Work Plan for submissions, renewals, and amendments of the regulatory projects and ensure full compliance with regulations of the products in charge.
• Evaluate applicable laws and regulations to determine impact on company activities. Identify and interpret relevant regulatory guidelines. Perform the assessment for the country related to any change notice communicated.
• Provide guideline and constant information to the commercial team about the best strategies to new product launches.

Requisition ID: 574707

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!