Regulatory Affair Specialist

Location: Penang, Malaysia 
Recruiter: Jason Tan

Purpose Statement

Reviews and Proposes improvements to the Supply Chain Organization with regards to Demand Planning, Field Inventory Management, Customer Service and Logistics in order to align and improve communication with the International and Global Supply Chain community.

Role Purpose

The role of Regulatory Affairs Operations Specialist is to provide support for the regulatory function to ensure efficient and compliant business processes and environment. The individual may execute tasks and play a consultative role by partnering across business functions.

Role Responsibilities

• Support the APAC RA function with the execution of regional RA strategic projects with a focus on building functional excellence and continuous improvement.
• Participates in the planning, execution and finalization of projects according to deadlines, within budget and acts as a liaison with project stakeholders to effectively communicate project expectations to team members and stakeholders in a timely and clear fashion.
• Complete compliance reviews, maintain and update standard operating procedures, policies, work instructions, and user guides, as needed.
• Provide RA Support to regional distribution centers for import for export notifications, Legal status/PRA requests
• Compile country specific regulatory intelligence from country Regulatory Affairs leaders and provide the consolidated intel to functional and quality management reviews.
• Lead the preparation and update of communications for regulatory metrics, newsletters, and other key communications.

Experience and Education

• 3+ Years working in medical device industry or other similar regulated industry
• Bachelors in science, business, project management or a related degree is desirable
• Experience working in regulatory affairs or related role desirable
• Project management experience

Skills

• High level of communication skills both verbal and written
• Strong analytical thinking and problem solving skills
• Attention to detail
• Good time management skills
• Ability to plan and prioritise workload
• Ability to work in a team with a collaborative approach
• Demonstrate resilience and perseverance
• Demonstrate adaptability and flexibility

Competencies

• Ability to solve problems
• Resilient when dealing with conflicting deadlines
• Ability to think innovatively and work towards continuous improvement
• Collaboration
• Ability to build strong internal and external relationships
• Remains calm under pressure
• Accountable for actions
• Uses a team approach to solve problems and maximise opportunities
• Influences outcomes through knowing who to involve and when

About Us

As a global medical technology leader for more than 35 years, our mission at Boston Scientific (NYSE: BSX) is to transform lives through innovative medical solutions that improve the health of patients. If you’re looking to truly make a difference to people both around the world and around the corner, there’s no better place to make it happen.

Requisition ID: 540656