Regulatory Affairs Analyst Jr.- 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 are dedicated to creating an inclusive environment where all employees can thrive. We are proud to be an equal opportunity employer and 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 student, preferably in the lasts years of the career.
- English. Advanced level. 
- Ideally with experience executing regulatory affairs activities in any health-related (Medical Devices preferred) company

MAIN TASKS:

- Submission of new licenses, amendments and renewals to the local health authority. 
- Regulatory responsible for the Global Distributor in Paraguay.
- Management and monitoring of RA KPIs.
- Provide regulatory support to other areas such as Marketing, Supply Chain and BU managers.

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.

Quality System Requirements

In all actions, demonstrates a primary commitment to patient safety and product quality by maintaining compliance to the Quality Policy and all other documented quality processes and procedures.

For those individuals that supervise others, the following statements are applicable:

• Assures that appropriate resources (personnel, tools, etc.) are maintained to assure Quality System compliance and adherence to the BSC Quality Policy.
• Establishes and promotes a work environment that supports the Quality Policy and Quality System.

Job Scope and Leveling Guidelines

Functional Knowledge

Requires basic conceptual and technical knowledge of theories, practices and procedures within own job function.

Business Expertise

Applies general business knowledge obtained through education or past experience with guidance from others.

Leadership

No supervisory responsibility; accountable for own contributions and meeting objectives with guidance more senior level roles/manager.

Problem Solving

Solves problems in repeatable situations; uses defined professional concepts and company policies and procedures; analyzes information and standard practices to make judgments.

Receives instruction, guidance and direction from more senior level roles/manager.

Impact

Contributions are usually limited to task-related activities; works within standardized procedures and practices to achieve objectives and meet deadlines.

Interactions (and Communications)

Exchanges straightforward information asks questions and checks for understanding.

Compiles and organizes data/ information to support discussions and inform decision making.

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.

Requisition ID: 570552

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!