Regulatory Affairs Coordinator

hace 7 días

Buenos Aires, Argentina Boston Scientific Corporation A tiempo completo

**Regulatory Affairs Coordinator - Argentina**:

- Work mode: Hybrid- Onsite Location(s): Buenos Aires, 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.

**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.
- 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.

**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 mínimal 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

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