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Senior Regulatory Affairs Specialist

Boston Scientific's hybrid workplace includes remote and onsite roles. By applying to this position, you will have the opportunity to discuss your preferred working location with your Talent Acquisition Specialist.

Remote Eligible:  Hybrid
Onsite Location(s): 

Mississauga, CA

Hiring Manager: Abby Chimonides
Recruiter: Savita Singhal

 

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.

 

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 localization efforts to ensure compliant device labelling.
  • Review marketing material to ensure adherence to applicable regulatory requirements.
  • Responsible for coordinating regulatory product holds to ensure import/sale of authorized product into Canada.
  • 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.

 

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.

 

 

Job Scope and Leveling Guidelines

 

Knowledge

A seasoned, experienced professional with a complete understanding and wide application of principle, theories, and concepts in the field.  Applies a full understanding of area of specialization to resolve a wide range of issues in creative ways.  General knowledge of other related disciplines, business unit function and cross group dependencies/relationships. This job is the fully-qualified career-oriented position.

 

Problem Solving

Develops solutions to a variety of complex problems of diverse scope and complexity where analysis of data requires evaluation of identifiable factors. Exercises authority and judgment within generally defined practices and policies in selecting methods and techniques for obtaining solutions. Has a broad knowledge of a variety of alternatives and their impact on the business unit.

 

Planning and Organization

Plans and organizes non-routine tasks w/approval. Initiates or maintains work schedule and priorities. Plans and organizes project assignments and maintains project schedules.

 

Discretion/Latitude; Supervision Received; Decision Making

Works under general direction regarding the direction and progress of projects and special assignments. Independently determines and develops approach to solutions.  Interprets, executes and recommends modifications to company policies. Assists in establishing departmental policies and procedures. Work is reviewed upon completion for adequacy in meeting objectives.

 

Business Relationships and Project Management

Establishes and cultivates a wide range of business relationships to facilitate completion of assignments. May interact with vendors. Participates in determining goals and objectives for projects. May lead projects within the function or department and/or represents a specialized field in larger project teams. Influences middle management on business solutions.

 

Impact

Contributes to the completion of specific programs and projects.  Failure to obtain results or erroneous decisions or recommendations would typically result in serious program delays and considerable expenditure of resources.

 

Liaison

Represents organization as a prime contact on contracts or projects. Interacts with senior internal and external personnel on significant matters often requiring coordination between organizations. Uses discretion, diplomacy and tact to resolve difficult situations. May escalate serious issues to manager.

 

Mentoring

Participates in the development of less experienced staff by setting an example, providing guidance, and offering counsel.

 

 

 

Requisition ID: 535724


Job Segment: Regulatory Affairs, Compliance, Medical Device, Law, Project Manager, Legal, Healthcare, Technology

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