The Regulatory Affairs Manager is responsible for the overall registration strategies, coordination, implementation, execution, monitoring and completion of product registration, assuring compliance with regulatory requirements in India and the Indian sub-continent.
Main Tasks and Responsibilities
· Registration of new products, product lifecycle management and product license maintenance in the assigned countries
· Preparing the Technical File for international registrations
· Maintain overview of registration timelines and communicate these with local and regional marketing teams frequently
· Responsible for implementing regulatory strategies for assigned “Medical Device” products in accordance with India and global regulations, guidelines and defined regulatory framework.
· Responsible for preparation and review of information required for development of regulatory dossiers for commercial products.
· Responsible for execution of registration process from dossier compiling to submission and approvals of assigned products in assigned countries within the Indian sub-continent
· Generate innovative solution to regulatory problems arising due to ever changing regulatory requirements worldwide and ensure compliance.
· Review of scientific information to assess technical merits and suitability of scientific rationale to ensure information is presented clearly and conclusions are adequately supported by data.
· Maintenance of administrative certificate and data viz. ISO Certificates, wholesale licence, registration certificates and any other certificates.
· To be vigilant for any change in regulatory guidance and inform the management immediately for the consequences of the same on current and the pipeline projects.
· Preparation, compilation and review of submission Dossier, Device Master File and registration application for import licence.
· Application for Import Licence via. “SUGAM” online portal. Review of deficiency letters, prepare justification with supportive documentation and submission of replies.
· Ensure to meet the timelines for submission of licence retention fees in advance to avoid any impact on supplies and maintain the device registration status.
· Keep an eye on applicable standards and their current revisions.
· Post Approval Supplements/Change Notifications to regulatory authority with-in the applicable timelines with supportive documentation as mentioned in the “conditions of import license”.
· Liaison with different government bodies to get clarifications/guidance on regulations.
· Perform post market surveillance compliance & reporting for the registered devices.
· Provide guidance and advice in legal and regulatory requirements including mandatory label markings.
· Maintain documentation related to all above topics including progress & record trackers.
· Keep abreast on updates/ changes to applicable regulations & requirements for the devices.
· 6-8 years’ experience of pre-market & post market regulatory work on compliance to Medical Device Rules (MDR) 2017, Drugs & Cosmetics Act & Rules governed by Central Drug Standard Control Organization (CDSCO).
· Should have knowledge about medical device regulations in EU & USA, India, Bangladesh, Sri Lanka and Nepal.
· Profound experience in medical devices registration to local Health Authorities for class III, IV in the region regulatory approvals and submissions
· Profound experience with international medical device (class II & III) regulatory approvals and submissions
· Proven track record of successful interactions with Health Authorities
· Excellent command of spoken and written English
· Effective communication and persuasion skills to interact across different levels and cultures
· Results-oriented in a dynamic environment
· Agility to handle and deliver on a multitude of projects, programs, and priorities paired with high sense for execution and teamwork
· Accountable personality with a structured and pragmatic working style
· Ability to build trust and drive engagements in others in a constantly changing environment
· Collaborative, emphatic and solution oriented individual
Minimum B. Pharm graduate. Preference will be given to M. Pharm graduates
- Being part of a dynamic, inspired and engaged team
- Take ownership as an expert
- Make an impact as one of our #ChangeMakers
Create a high performance culture through encouraging others, and role modelling Straumann’s Core Behaviors:
- Focus on Customers: Think commercially, build genuine relationships, and find solutions.
- Collaborate: Build and maintain effective working relationships.
- Take Ownership: Deliver what you promise, tackle challenges, go for it with passion!
- Create Opportunities: Create new and better ways to be successful. Be innovative and think big!
- Build Trust: Be honest, reliable, and win confidence.
- Engage: Encourage others to do their best and recognize their achievements.
- Communicate Effectively: Share information and knowledge, engage in difficult, crucial conversations with a sense of urgency.
- Be Agile: Embrace change, adapt proactively, have a can-do attitude.
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