VACANCY AT NANO THERAPEUTICS PVT LTDAS MANAGER REGULATORY AFFAIRS
At Nano, they are working to help people live not just longer, but better, in the area we serve.
They, design, develop, Manufacture & Supply Vascular Stents, Stent Systems & Support Devices. They are actively pursuing development of Interventional Bronchology and ENT medical devices.
Post : Manager RA
As a Manager – Regulatory Affairs with this fast growing, Class III medical device company, you will be responsible for product submissions, license renewals, periodic updates and registrations to regulatory agencies. You will organize regulatory information and track and control submissions, review and advice on labeling for compliance with regulatory filings, review product changes for impact on regulatory filings worldwide, and research regulatory issues and provide guidance and advice to colleagues.
• Collect and coordinate information and prepare regulatory documentation for submission to regulatory agencies or to commercial partners, advice on the submission strategy
• Represent RA department in assigned project meetings and provide regulatory guidance to ensure adherence with global regulatory requirements as appropriate
• Maintain up-to-date knowledge on domestic and international regulatory requirements, regulations, standards, and guidance and ensure effective communication to the project teams and management.
• Manage interactions with international agents, distributors, and consultants to clearly identify regulatory requirements and changes on an ongoing basis
• Directly interact with regulatory bodies in the EU and internationally in a respectful, professional manner to ensure projects remain on track and issues are identified and resolved as expediently as possible
• Maintain regulatory files/database and chronologies in good order
• Establish and maintain system for tracking changes in documents submitted to agencies or partners
• Review and approve documents change orders, technical documents, test protocols and reports, risk management documents, and other documents as a key member of the project teams
• Review and approve labeling and promotional materials to ensure compliance with international requirements
• Author and prepare regulatory submissions, including not limited to: Technical File, Design Dossier, PMS, Clinical Follow ups, Manufacturing and Marketing Applications
• Participate and support external audits (FDA, CE Notified Body, ISO 9001, ISO 13485, Third party Audit) and internal audits.
• Review advertising and marketing material for appropriateness and compliance to regulatory requirements and laws.
• Supervise Regulatory Affairs consultants as required.
• Timely compile materials for license renewals, updates and registrations
• Provide the regulatory reviews of customer complaints and define the regulatory reportability
• Responsible for timely registration of the facility
• Maintain current knowledge of FDA and international regulation, guidance and standards applicable to company products
• Actively participate in evaluation of regulatory compliance of document / product / process /test methods changes
• Represent Regulatory Affairs on R&D product development project teams to ensure all regulatory requirements are met throughout the development process.
• Participate in research of regulatory issues and dissemination regulatory information to Production, QA, QC and R&D departments and senior management as required.
• Up to 15% travel is anticipated
Specific Skills, Knowledge & Behaviors:
(to perform the job successfully, an individual should demonstrate the following competencies):
• Experience with Medical Device Regulation CE, ISO 9001,13485, MDD & Indian Medical Device rules.
• Strong interpersonal skills including ability to interact with high degree of diplomacy
• Knowledge of EU and international medical device regulatory requirement
• Experience with Class II/III devices
• Experience in CE, PMS, Technical File, Design Dossier
• Ability to work effectively in a team environment
• Ability to interface with all levels of management and regulatory body representatives.
• Excellent written and oral communication skills
• Strong organizational skills
• Ability to work in a fast-paced, technically challenging environment where drive is critical to success
• Maintain corporate confidentiality at all times.
Qualification :Bachelor’s/Master’s degree in a scientific discipline or equivalent is required.
Experience: Minimum 5 years of experience in Regulatory Affairs with Class III devices strongly preferred
Location :Plot No D54/2, Hojiwala Industrial Estate, Road No. 23, Near Gate No. 3, Sachin Palsana Highway, Surat, Gujarat 394230
Industry Type : Pharma
Interested candidates can mail their updated resume to undersigned.
Placement Manager (IGMPI)
Telephone: +91 8448775080; 0120-2427175; 0120-4375280