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SR Strategy Services Llp

2 Job openings at SR Strategy Services Llp
Regulatory Executive Medical Devices noida 0 - 3 years INR 4.75 - 7.5 Lacs P.A. Work from Office Full Time

Role & responsibilities Prepare, compile, and assist in submission of regulatory applications/dossiers for medical devices and IVDs under MDR 2017. Support licensing/registration processes (Forms MD-5, MD-14, MD-15, MD-16, MD-24 etc.) for multiple products and clients. Liaise with CDSCO, State Licensing Authorities, and notified bodies during submission and approval processes. Track and manage multiple regulatory projects simultaneously, ensuring adherence to timelines. Maintain regulatory documentation, trackers, and compliance records for all client projects. Coordinate with SRSS internal teams and client stakeholders to collect required technical and compliance documentation. Monitor regulatory amendments, CDSCO notices, and guidance impacting medical devices and IVDs. Support post-approval activities including license renewals, variations, and responding to authority queries. Preferred candidate profile Bachelors/Masters degree in Pharmacy, Life Sciences, Biotechnology, Biomedical Engineering, or related discipline. 13 years of experience in regulatory affairs for medical devices and/or IVDs under Indian MDR 2017 Familiarity with CDSCO online portal (MD Online System), device/IVD classification and submission formats. Understanding of ISO 13485 and Quality Management Systems preferred. On-site role based at Noida, Uttar Pradesh Strong organizational skills to manage multiple projects concurrently . Excellent written and verbal communication skills. Proficiency in MS Office Suite.

Executive Assistant To Chief Executive Officer noida 2 - 6 years INR 3.0 - 6.0 Lacs P.A. Work from Office Full Time

Role & responsibilities Coordinate CEOs communications - draft, review and send communications Schedule appointments, and maintain and update CEO' calendar Coordinate travel arrangements, prepare itineraries, plan logistics, and submit expense reports Maintain a repository of various records and documents for CEO Uphold a strict level of confidentiality Develop and sustain a level of professionalism among staff and clients Develop and maintain a filing system for important documents and records. Track and manage budgets for projects as directed by the CEO. Liaise with other administrative staff to ensure smooth office operations. Oversee office management tasks, ensuring supplies and equipment are available and maintained. Preferred candidate profile Bachelor's degree required or equivalent work experience Proven experience as an Executive Assistant reporting directly to senior management Exceptional organizational and time management skills. Ability to multitask and prioritize workloads effectively. Strong understanding of office management responsibilities and procedures. Proficient in Microsoft Office (Outlook, Word, Excel, and Power Point), Adobe Acrobat etc. Ability to pay attention to detail Proficiency in collaboration and delegation of duties Excellent verbal and written communications skills Strong interpersonal skills and the ability to build relationships with key clients Healthcare sector experience is a plus