Manager - Regulatory Affairs - Medical Devices
5 days ago
About are global talent research, insight and pipelining specialists with offices in the UK, USA, Singapore, Malaysia, Hong Kong, Dubai, and India. Our international reach has helped us to understand and penetrate specialist markets at a global level. In addition to this, our service is also extended to complement our clients in-house our client
As a Regulatory Affairs Manager, you will be responsible for:
- Ensuring all products comply with applicable laws, regulations, and standards as per Indian laws.
- Staying updated on regulatory changes and assess their impact on the company's products or processes.
- Either preparing or coordinating with originator, review, and submit regulatory documents such as dossiers, technical files, and applications for product approval or licensing.
- Necessary follow-ups with regulatory agencies to get approval of the medical devices / pharmaceutical products.
- Working with Originator, and marketing teams to ensure product alignment with regulatory requirements.
- Leading or assisting in regulatory audits conducted by agencies or certification bodies.
- Identifying and mitigating regulatory risks that could impact product approvals or market access.
- Developing and implementing regulatory strategies to accelerate market entry and ensure sustained compliance.
- Conducting training sessions for cross-functional teams on regulatory requirements and best you already have
- Bachelor's degree in a related field. Advanced degree (e.g., MBA, MS, or Ph.D.) is an advantage.
- Strong knowledge of regulatory requirements (CDSCO, FDA, EMA, MHRA, TGA, etc.) and global standards (ISO, ICH, etc.).
- Excellent project management and organizational skills.
- Ability to analyze and interpret complex regulations.
- Proficient in regulatory writing and submission tools.
- Strong communication and interpersonal skills.
- Ability to manage multiple projects and meet - 7-10 years of experience in regulatory affairs, with a proven track record of successful submissions and approvals. Experience in handling registration of Medical Devices and getting approval.
Other details
Target industry Medical device.
Location Delhi.
(ref:iimjobs.com)
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