ZEISS Group
Location
Bangalore | India
Job description
Role : Regulatory Manager Work Location : Bangalore
Key Responsibilities & Accountabilities (Tasks & Deliverables): General and Task Management: Ensure compliance with all products related regulatory compliances such as (not limited to): Medical device regulations of India and SAARC countries, Medical device regulations of all exporting countries, AERB compliances, Legal metrology compliances, WPC compliances, BIS certifications, MOEF compliances, Drug Sale License etc. Responsible for preparing the regulatory strategy for the organization and support the management to take appropriate decisions. Provides leadership and guidance (including training) to other members of the RA staff as well as to cross-functional team members and development teams. Design, establish and implement a standardized regulatory function processes across the organization. Independently interacts and builds good working relationships with competent authorities. Liaison with the regulator -drugs controlling authority/consultant for the registration of the products. Conducts regulatory due diligence, Identify the business risk and prepares the mitigation plan. Reporting to regulatory authorities in case of changes/Incidents etc. Ensure all required accreditation is complied with different regulatory bodies. Act as the contact person for internal and external regulatory inquiries, including ZEISS internal RA officer networks. Continuously monitor, gather, analyze, assess and communicate regulatory market requirements or changes for India and related local markets. Support local and global post-market surveillance activities and clinical evaluation. Responsible for the coordination or escalation of critical incidents in the Region and reporting to the regulatory authorities. Provides support for any recall management, RA related complaints management and resulting measures. Support R&D team and digital innovation team to comply with the regulatory requirements. Assists with audits and inspections, if required Responsible to do the new product assessment and change impact assessment. Obtain a drug license for the distribution of the medical device. Ensure compliance to the Drug sale license or MD42 requirements at all ZEISS locations. Responsible for clarification of regulations governing local approvals, in close cooperation with local Quality Representatives, other ZEISS RA Managers, Conformity Representatives, and related officers and is point of contact for authorities (approvals etc.). Performs other related duties and responsibilities, on occasion, as assigned. Key Requirement/Minimum Eligibility : Bachelor’s Degree OR an equivalent combination of education and experience 13+ years in regulatory affairs – Healthcare / medical device industry In-depth understanding of medical device regulations which includes but not limited to the followings, the Drugs & Cosmetics Act, the Drugs & Cosmetics Rules, the Medical Device Rules, The Legal Metrology Act and Rules. Sound knowledge of international laws, standards, and regulations for licensing medical devices and of the business processes of medical device manufacturers/import/ sale (e.g., India MDR 2017, MDD/MDR,) Good knowledge of ISO standards such as ISO 9001, ISO 13485 Ability to work in a highly matrixed and geographically diverse business environment. Strong leadership skills, including the ability to set goals and provide positive and constructive feedback respectfully to build positive relationships and improve business results. Ability to work effectively within a team in a fast-paced changing environment. Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization. Multi-tasks, prioritizes and meets deadlines in timely manner. Strong organizational, planning, and follow-up skills and ability to hold others accountable. Additional requirements : Awareness about the Medical device rules and regulations of SAARC countries Work experience on working with multiple international stake holders. Good knowledge about the CDSCO organization About us : ZEISS is an internationally leading technology enterprise operating in the fields of optics and optoelectronics. In the previous fiscal year, the ZEISS Group generated annual revenue totaling 10 billion euros in its four segments Semiconductor Manufacturing Technology, Industrial Quality & Research, Medical Technology and Consumer Markets (status: 30 September 2023). With around 43,000 employees, ZEISS is active globally in almost 50 countries with around 30 production sites, 60 sales and service companies and 27 research and development facilities (status: 30 September 2023). Founded in 1846 in Jena, the company is headquartered in Oberkochen, Germany. The Carl Zeiss Foundation, one of the largest foundations in Germany committed to the promotion of science, is the sole owner of the holding company, Carl Zeiss AGJob tags
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