Senior Regulatory Affairs Specialist
4 days ago
The Senior Regulatory Affairs Specialist will ensures rapid and timely approvals for respective product lines by plans on all product registration, manage all product registrations' preparation and documentation. Interacts with regulatory agency personnel in order to expedite approval of pending registration and answers any questions on product documentation. Provide management team with regular updates on product registration and new regulations from government body.
Key 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 for change notifications 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 commercial team and internal stakeholders.Complete the mandatory Quality training subject to the defined timeline. And ensure compliance with internal Quality system and policy.Requirements:
Bachelor's degree in Pharmacy, and must be a registered Pharmacist.Minimum 5-years of working experience in regulatory affairs within medical device industry.Strong in-depth conceptual, practical, technical, and/or functional knowledge of principles and theories in local country regulatory policies.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 skills.Minimum intermediate level in MS Office skill.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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