Regulatory Affairs Specialist

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:

The role is to ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation.  This person will interact with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.  This person also provides management team with regular updates on product registration and new regulations from government body.

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.

COMPETENCIES:

Functional Knowledge

• Requires expanded conceptual and technical and/or functional knowledge in own job function

• Broadens capabilities in applying concepts in job function

Business Expertise

• Demonstrates working knowledge of business and industry practices and company processes to accomplish own work

Leadership

• No supervisory responsibility; accountable for own contributions and meeting objectives

Problem Solving

• Uses and exercises judgment to solve problems in straightforward situations and determine appropriate action/solutions.

• Works under general direction from more senior level roles/manager

Impact

• Impacts quality of own work and the work of others on the team; works within guidelines and policies

Interactions (and Communications)

• Explains factual information of limited complexity to others in straightforward situations

• Organizes, presents and explains data/ information, primarily to internal audiences

Requisition ID: 622884

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!