Regulatory Affairs Specialist
4 weeks ago
Summary
Ensures rapid and timely approvals for respective product line by plans on all product registrations, manage all product registrations' preparation and documentation. Interacts with regulatory agencies’ personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registrations and new regulations from authority and agencies.
Key Responsibilities
- Provides input on regulatory-related issues associated with compliance and achieving the business plan. Provide the management team with regular updates on product registrations status and/or timely escalation with proposed solution.
- Preparing, coordinating and submitting regulatory applications to the local health authority and agencies.
- Ensure product registrations are reviewed and renewed as required.
- Ensure product changes/ amendments are approved in timely manner and work with relevant stakeholders to minimize business disruption.
- To keep abreast of local regulatory updates, guidelines and new regulations, and its implementation.
- Establishes relationships with local medical device industry groups and works independently or with industry peers for advocacies to local health authority and agencies in matters of regulatory issues and to influence local policies.
- To actively liaise with regional/ global partners pertaining to regulatory affairs and providing support in the development of regulatory strategies and plans.
- Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.
- Support internal audit or any external audit.
- Review and obtain approval, where necessary, for Promotional Materials.
- Supports any other relevant activities or as assigned.
Key Skills and Experiences
- Prior experience of minimum 3 to 5 years in Medical Device Regulatory Affairs
- Knowledge of GDPMD will be value added.
- Knowledge of regulatory submissions and requirements for other ASEAN countries will be value added.
- Solid oral and written communication skills (both English and Indonesian)
- Strong analytical and critical thinking
- Team player
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
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