Share this Job

RA Manager Job

Apply now »
Apply now

Apply for Job

Date: Feb 11, 2019

Location: Beijing, 11, CN

Company: Boston Scientific

Purpose

  • The role is critical in linking with the executive management team for the country and in the relationships with the competent authorities/health authorities. Develops and manages a strong relationship with the competent authorities (covering product notifications, materiovigilance, field actions and any other specific program). Provides regulatory support and expertise to the local organizations. Manages the impact of the regional and national regulations to the business. Supports lobbying activities.

Responsibilities

  • Regulatory: Secures regulatory approvals according to specific country requirements and applicable laws; Monitors local as well as regional regulatory environment and providing updates to business partners; Supports registration activities of distributors in the country/region; Prepares and executes clinical trial notifications to competent authorities; Communicates with competent authorities on field corrective actions, vigilance etc.
  • Business: Participates in strategic planning for the region providing regulatory input; Maintains an active knowledge of the status of pending approvals and registrations; Provides regulatory related information to business country heads, sales managers and customer services; Participates in regional/country business reviews and provides regulatory input; Supports local customer services and tender specialists in terms of providing regulatory documents, translations, solving regulatory issues; Provides literature and advertising review for locally produced promotional materials; Raises non-compliance issues and business exposures to business country heads and head of RA; Acts as a link to Quality team.
  • Influencing: Builds trusted relationship with competent authorities in the region; Participates in relevant working groups of industry associations; Takes part in lobbying activities either as BSC representative or via industry association.

Management Requirements

  • May lead a group or team of employees in the achievement of organizational goals. Guide, coach, direct, and develop direct reports, and if applicable, drive those practices throughout their organization.
  • Foster a diverse workplace that enables all participants to contribute to their full potential in pursuit of organizational objectives.
  • May direct and control the activities and budget of one or more functional areas, divisions, product groups, projects/programs and/or operations.
  • Monitor and ensure compliance with company policies and procedures (e.g. federal/country and regulatory requirements).

Job Scope and Leveling Guidelines

  • Scope: Accomplishes results through lower level subordinate supervisors or through experienced professional employees who exercise significant latitude and independence in their assignments. Monitors progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors external environment in area of technical or professional responsibility. Receives assignments in the form of objectives with goals. Provides direction to employees according to established policies and management guidance. Often heads a centralized functional activity.
  • Supervision Received: Works under minimal supervision. Independently determines and develops approach to solutions. Work is reviewed upon completion for adequacy in meeting objectives.
  • Supervision Provided: Provides direction and guidance to lower level subordinate supervisors or through experienced professional employees. Acts as an adviser to subordinates and may become actively involved, as required, to meet schedules and resolve of and ...

BSC


Job Segment: Law, Compliance, Strategic Planning, Manager, Advertising, Legal, Strategy, Management, Marketing