Regulatory Affairs Manager

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):

Kangnam-gu, KR

Title: RA Manager

An exciting opportunity

Boston Scientific Korea is seeking for an initiative and responsible RA supervisor. Our global mission is to transform lives through innovative medical solutions that improve the health of patients. The vision of Boston Scientific RA is to be a strategic business partner dedicated to accelerating regulatory approvals, through high performance and innovative solutions, enabling exceptional patient care. If you want to develop your RA competency and contribute to improve the quality of patient lives, please join us.

Purpose Statement

The purpose of this role is to provide regulatory expertise to ensures rapid and timely approvals for respective product lines by plans, manage preparation and documentation of all product registrations including his/her direct report’s. In addition, this role requires to interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation.

Key Responsibilities

Prioritize and develop strategies on product registration including KGMP certification for his/her respective product lines.
Preparing, coordinating and submitting regulatory applications to the local health authority.
Supervising his/her direct reports including administration of performance management and individual development plans.
Provides input on regulatory-related issues associated with compliance and achieving the business plan.
Monitor emerging trends regarding industry regulations to determine potential impacts on organizational processes and share the changes with internal stakeholders in a timely manner.
Review materials such as marketing literature or user manuals to ensure that regulatory agency requirements are met.
Participate in global projects with regard to RA process and lead local RA projects.
Build a constructive and trusted relationship with local health authorities through quality submission, active cooperation on any MFDS requests and scientific challenges to regulations. This should include guidance on alternative solutions to country regulatory needs.
Establishes and maintains relationships with local medical device industry groups and works with industry peers to respond accordingly to 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 as well as local regulations to achieve stated objective.

Basic Requirements

At least 14 years of RA experiences in medical devices.
Science/Engineering related majors preferred.
Good written and verbal communication skills in English.
Problem solving and strategic planning skills.
Interpersonal and organizational skills.

Job Segment: Regulatory Affairs, Medical Device, Compliance, Marketing Manager, Strategic Planning, Legal, Healthcare, Marketing, Strategy

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