Ashland India Private Ltd Hiring Chemistry & Chemical Engineering
Creating good chemistry isn’t just about what happens when you add the right ingredients together. It’s about what happens when the right people are one of the ingredients. Chemistry and chemical engineering job opening 2022, Regulatory affairs job opening 2022, Check out all the details on the same below:
Job Title: Regulatory Affairs Manager
Location: IN-MUMBAI-GHATKOPAR
Eligbility Criteria & Experience:
- B.S. Degree in Chemistry or Chemical Engineering or a related discipline.
- 5-8 years of experience within the regulatory function in a medical device company
- Experience with medical device design controls and global regulatory submissions (including but not limited to 510(k) and CE mark)
- Experience working within and complying with ISO 13485, 21 CFR 820, and EU MDR
TECHNICAL KNOWLEDGE, SKILLS AND ABILITIES:
- Regulatory Expertise – Demonstrated knowledge of medical device design controls requirements, submissions, registrations, product/process change evaluation, review of labeling and promotional materials and interaction with regulatory authorities would be a plus.
- Project Management Abilities – Able to provide problem solving and project management abilities to lead or participate in regulatory compliance/submission projects
- Communication Skills – Able to clearly and effectively communicate verbal and written information appropriately to an audience. Able to deliver information in a formalized and group setting. Able to translate complicated and/or technical information in a simplified format that can be easily understood.
- Computer Skills – Good knowledge of Office tools (Microsoft Office Word, Excel, and PowerPoint). Ability to interpret and analyze statistical data. SAP experience a plus.
Minimal Travel Required
POSITION SUMMARY:
The primary role of this position is to support regulatory compliance, maintenance and continual improvement of the Diagnostic Films group’s medical devices while safeguarding alignment with applicable regulatory requirements, business objectives, and customer needs.
- Ensure regulatory compliance with relevant global medical device regulations, including but not limited to FDA 21 CFR 820, EU MDR, Canada, UK requirements, and Switzerland regulations
- Manage the applicable sites FDA establishment registrations
- Maintain FDA listing for all medical devices in the FDA listing/registration system
- Maintain Canadian MDEL registration up to date
- Lead medical device design control activities per 21 CFR 830 requirements
- Lead design control documentation: design and development plan, design input, design verification, and other applicable regulatory documentation
- Lead CE mark technical dossiers, complete the required EU MRD documentation required to demonstrate compliance
- Lead 510(k) submissions
Lead 510(k) letters to file to document all changes to our 510(k) cleared devices - Lead FDA’s meetings, interactions and consultation for our medical devices
- Support EU, UK and Swiss authorized representatives providing updated technical dossier documentation and providing advice regarding labelling requirements and up to date information regarding regulatory changes for these regions.
- Support Chinese medical device technical dossiers
- Global Regulatory liaison to support EU, UK, Switzerland China registrations and requirements
- Obtain FDA CFGs to support international submissions
- Review and approve NPIs (new product introductions) related to all medical devices
- Request and maintain the UDI requirements/barcodes for all devices in the GS1 system
- Maintain up to date UDI requirements in the FDA GUDUI database
Support U.K and Swiss product/site registration in the applicable government systems - Review and approve labels for all our medical devices
- Review and approve as applicable change controls to assess regulatory impact
- Review and approve risk management documentation
- Review and approve Software related requirements related to FDA and IEC 62304 requirements
- Support as required FDA observations to ensure regulatory compliance.
- Support customer requests and questionnaires related to Regulatory items
- Review distributor/customers agreement related to Regulatory requirements
- Review and approve labelling and marketing materials for all our medical devices
- Develop relevant Regulatory best practice document/procedures as necessary
Support distributor’s regulatory technical documentation for their submission
Review distributor regulatory compliance status - Lead SAP block request related to regulatory items
- Responsible for the evaluation and submission of any global safety related reports to regulatory agencies
Main point of contact for Global authority agencies requesting regulatory information - Participate in QA management reviews
- Review applicable QA procedures to ensure RA global compliance
- Participate in INNOVA projects and lead Global product classification and registration requirements
- Lead medical device regulatory intelligence efforts to ensure global compliance.
- Additional Global Life Science Business unit regulatory projects
Apply Online
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