Ashland India Private Ltd 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 EXPERIENCE AND EDUCATION REQUIREMENTS: 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 In more than 100 countries, the people of Ashland LLC. (NYSE: ASH) provide the specialty chemicals, technologies and insights to help customers create new and improved products for today and sustainable solutions for tomorrow. Our chemistry is at work every day in a wide variety of markets and applications, including architectural coatings, automotive, construction, energy, personal care and pharmaceutical. Visit www.ashland.com to see the innovations we offer. At Ashland our vision is to be a leading, global specialty chemicals company whose inspired and engaged employees add value to all we touch. In fact our people, employees, customers and vendors define who we are. They are the driving force behind everything we do. Not only do we value our customers but we value our employees, and we work to offer them a dynamic and challenging environment. We hold ourselves to high standards at Ashland, and we value integrity and honesty. Ashland has a history of attracting the best people and keeping them. The reasons are simple: industry competitive salary and benefits, pay-for-performance incentive plans and a diverse work environment where employees feel challenged and valued. People come to Ashland and stay. As a growing Fortune 500 specialty chemicals company, we offer opportunities for development and advancement throughout our global organization. Our values define who we are and what we care about as a company. If you are looking for a relationship with a company instead of simply a job, this may be a great fit. Ashland is proud to be an Equal Opportunity Employer Minorities/Women/Veterans/Disabled/Gender Identity/Sexual Orientation. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, gender identity, sexual orientation, national origin, or protected veteran status and will not be discriminated against on the basis of disability. NOTE: We do not accept resumes from external staffing agencies or independent recruiters for any of our openings unless we have a signed recruiting agreement in place to fill a specific position.