Regulatory Affairs Coordinator - Argentina

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.

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.

Purpose statement

Ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.  Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.  Provide management team with regular updates on product registration and new regulations from government body.

What we are looking for in you

Pharmacy and biochemistry students or graduates.

Exclusive experience in regulatory affairs

Advanced English is a must

2 people in charge

Tasks

• Registration of medical product classes I to IV.
• Submission of registration modifications and renewals.
• Request and processing of required documentation.
• Responding to deadline cuts.
• Evaluation of the regulatory impact of changes in products registered in Cono Sur.
• Follow-up of dossiers under evaluation.
• Maintenance of the Regulatory Affairs database.
• Drafting of local procedures.
• Coordination of the RA sector of cno sur
• liaison with the planning and business areas for the launching of registrations
• contact with health authority.
• distributor management

Key Responsibilities

•          Provides input on regulatory-related issues associated with compliance and achieving the business plan.

•          Prioritize and plan on product registration for his/her respective product lines.

•          Preparing, coordinating and submitting regulatory applications to the local health authority.

•          Maintain an active knowledge of the status of pending approvals and shepherd registrations through the approval process.  Provide the management team with regular updates on product registration.

•          Ensure product registrations are reviewed and renewed as required.

•          Establish and implement plans to maintain a trusted relationship with the local health authorities through regular meetings, discussions, training and education.

•          Lobby the local health authorities using constructive/scientific challenges to regulations.  This should include guidance on alternative solutions to country regulatory needs.

•          Supports tender operations by timely supply of accurate regulatory documents.

•          Establishes relationships with local medical device industry groups and works with industry peers to lobby the Competent Authorities in matters of regulatory issues and to influence local policies.

•          Establish and maintain a good working relationship with regional RA peers to gain positive & timely support for document preparation.

•          Serves as regulatory consultant to marketing team and government regulatory agencies.

•          Complete the mandatory Quality training subject to the defined timeline.  And ensure compliance with internal Quality system and policy.

Job Scope and Leveling Guidelines

Functional Knowledge

•          Requires specialized and comprehensive technical and/or functional knowledge in own job function or field and has full understanding of other related job functions

•          Leverages this knowledge to recommend new and/or improved work processes, typically at an area level impacting various teams

Business Expertise

•          Applies knowledge of business and industry best practices and how own area integrates with others to achieve objectives to drive results

•          Is aware of the competition and the factors that differentiate them in the market

Leadership

•          Acts as a resource and mentor for colleagues with less experience

•          May lead projects with manageable risks and resource requirements, often broader, cross-functional projects

Problem Solving

•          Solves complex and diverse problems, takes a new perspective on existing solutions and exercises judgment based on the analysis of multiple sources of information using specialized knowledge of various alternatives and their impact on the business

•          Works independently within broad guidelines and policies, receives minimal guidance

Impact

•          Impacts the ongoing achievement of customer, operational, project/program or key business/organizational/service objectives and recommends improvements within area of responsibility

Interactions (and Communications)

•          Explains difficult or sensitive information to facilitate productive discussion; works to build consensus

•          Regularly leads discussions and makes presentations in cross-functional meetings, effectively presenting information to explain recommendations and implications

The above statements are intended to describe the general nature and level of work being performed by people assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of personnel so classified. Job-specific training requirements associated with responsibilities and tasks personnel perform are established and demonstrated through their individual learning plan.

Please contact your local EH&S department for more information on physical requirements.

Requisition ID: 573708

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!