Regulatory Affairs Manager
|Job Title:||Regulatory Affairs Manager|
|Contact Name:||David Walsh|
- Manage domestic and international regulatory activities and issues occurring at Boston Scientific Ltd., including compiling submissions for US, EU and International approvals for Class III and other devices. Taking responsibility for regulatory activities related to new product manufacturing and market introduction, as well as regulatory issues relating to labelling, releases, and change orders.
- Manage departmental procedure development and implementation.
- Preview device labelling, product and manufacturing changes for compliance and applicable regulations.
- Provide regulatory strategies for new product introduction.
- Manage regulatory activities in maintaining regulatory compliance status of products in commercial distribution.
- Manage interactions and relationships with external regulatory bodies on behalf of the company in relation to product approvals and post-market compliance
- Provide updates on regulatory requirement changes, either on individual product specification or quality systems and manage regulatory aspects on implementation of new regulations or requirements
- Interface with divisional regulatory colleagues on regulatory matters relating to new product submissions or management of changes to existing devices.
- Assist in the preparation and the management of regulatory and quality system audits.
- Contribute to the quality and regulatory team process at Boston Scientific.
- Strong team member with the ability to identify and drive quality and compliance improvements.
- Good administrative/organisational ability with attention to detail is required.
- Excellent communications skills.
- Establish and support a work environment of continuous improvement that supports BSC’s Quality policy, Quality System & the appropriate regulations for the area.
- Ensure employees are trained to do their work and their training is documented.
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 in order 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.
- 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
Accomplishes results through professional specialist employees or subordinate managers and supervisors who exercise significant latitude and independence in their assignments. Provides direction and monitors progress toward departmental goals; monitors costs of projects and of human and material resources within a department or unit; monitors company-wide indicators such as market share and profitability; monitors the external environment in the area of technical or professional responsibility. Subject to approval, modify the organizational structure of centralized functions and units. Often responsible for managing a staff function of the company.
Works under consultative direction toward predetermined long-range goals and objectives. Assignments are often self-initiated. Determines and pursues courses of action necessary to obtain desired results. Work is reviewed by senior management in terms of meeting the organization’s objectives and schedules.
Provides direction and guidance to professional specialist employees or subordinate managers and supervisors. Provides guidance to subordinates within the latitude of established company policies. Manages, perhaps through subordinate supervisors, the coordination of the activities of a section or department with responsibility for results, including costs, methods, and staffing. Evaluates the performance of and assists in career development planning for subordinates.
Works on issues of large and diverse scope where analysis of situations or data requires expert knowledge of area of expertise and in-depth understanding of organizational objectives. Implements strategic policies when selecting methods, techniques, and evaluation criteria for obtaining results. Establishes and assures adherence to budgets, schedules, work plans and performance requirements. In some instances, this manager may be responsible for managing a staff function and may not have subordinate managers.
Establishes operating policies and procedures that affect immediate subordinate organizational units and may have company-wide effect. Interprets, executes, and recommends modifications to organizational policies. Develops and/or identifies new work processes and the improved utilization of human and material resources within the assigned or related functions or groups.
Operations Involvement/Direct Work Involvement
Functions as an advisor to subordinates supervisors or staff members to meet schedules or resolve technical or operational problems. Develops and administers budgets, schedules, and performance standards. Investigates and solves problems that impact work processes and personnel within or across units or departments.
Responsible for all projects assigned to the organizational unit. Defines projects based on identified strategies and goals. Manages projects of moderate to large scope including schedules, costs and resources. May lead or participate in cross-functional teams.
Planning and Organization
Creates mid- to long-range plans to carry out objectives established by top management. Develops and calculates a budget for a department or group to meet organizational goals; forecasts future departmental needs including human and material resources and capital expenditures; recommends or modifies the structure of organizational units or a centralized functional activity subject to senior management approval.
Assignments are expressed in the form of objectives; makes decisions regarding work processes or operational plans and schedules in order to achieve the program objectives established by senior management. Exerts influence in the development of overall strategy, objectives and long-range goals of the organization. Erroneous decisions or recommendations would normally result in critical delays and modifications to projects or operations; cause substantial expenditure of additional time, human resources, and funds; and may jeopardize future business activity.
Influence and Leadership
Develops and communicates a vision for the organizational unit assigned. Builds consensus for operating goals that are in alignment with the division. Provides leadership to assigned staff and supervisors by communicating and providing guidance towards achieving department objectives.
Frequently interacts with subordinate supervisors, equivalent level managers, and/or customers, normally involving matters between functional areas, other company divisions or units or customers and the company. Conducts briefings and technical meetings for internal and external representatives concerning operational decisions, scheduling requirements, or contractual clarifications.
- Degree (HETAC Level 8) qualified, in a relevant field with a minimum of 8 years' work experience in a medical device environment
- People management experience is desirable
- Direct regulatory affairs experience with higher class devices desirable
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