Regulatory Affairs Specialist Operation, Growth Market

Key Responsibilities

• Develop gold standard quality system processes for the regulatory function.
• Lead internal and external audit activities.
• Lead implementation of global/regional programs, and special projects.
• Work with Regional/Country/Business Unit RA Team to identifies and lead process improvement activities.
• Streamlining of various internal processes with regards to change management, labelling, reporting and tracking.
• Lead the regulatory component of the management review process and RA functional review.
• Develop training resources for the Regulatory Affairs function. Leads training of business partners and stakeholders on regulatory processes and requirements.
• Leads operational activities, such as labelling, localisation, translations, systems, and tender requests.
• Lead regulatory compliance activities, i.e. regional regulatory intelligence, regulation change impact assessment (RegMap) and execution activities.
• Reporting and Tracking (new product, Change Notification, Renewals):
  • Maintenance & update of internal RA tool.
  • Preparation of RA reports for demand planner using RA tool.

Requirements

• Minimum a Bachelor’s Degree in related fields such as Pharmacy, Pharmaceutical Science, Science, Biomedical Science, etc.
• Minimum 3-years of working experience in regulatory affairs within medical device or pharmaceutical industry.
• Able to work independently guided by company policies, guidelines and procedures, receiving guidance on complex and unprecedented problems.
• Quick learner with the ability to handle multiple tasks simultaneously, maintain focus, and adapt to a variety of challenges.
• Critical thinker with good problem-solving skill and excellent communication skill.
• Minimum intermediate level in MS Office skill and Windchill (good to have).

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!