Job
Description
Thank you for your interest in working for our Company. Recruiting the right talent is crucial to our goals. On April 1, 2024, 3M Healthcare underwent a corporate spin-off leading to the creation of a new company named Solventum. We are still in the process of updating our Careers Page and applicant documents, which currently have 3M branding. Please bear with us. In the interim, our Privacy Policy here: https://www.solventum.com/en-us/home/legal/website-privacy-statement/applicant-privacy/ continues to apply to any personal information you submit, and the 3M-branded positions listed on our Careers Page are for Solventum positions. As it was with 3M, at Solventum all qualified applicants will receive consideration for employment without regard to their race, color, religion, sex, sexual orientation, gender identity, national origin, disability, or status as a protected veteran. Job Description: Regulatory Affairs & Compliance Manager (Gurgaon) (Solventum) 3M Health Care is now Solventum At Solventum, we enable better, smarter, safer healthcare to improve lives. As a new company with a long legacy of creating breakthrough solutions for our customers’ toughest challenges, we pioneer game-changing innovations at the intersection of health, material and data science that change patients' lives for the better while enabling healthcare professionals to perform at their best. Because people, and their wellbeing, are at the heart of every scientific advancement we pursue. We partner closely with the brightest minds in healthcare to ensure that every solution we create melds the latest technology with compassion and empathy. Because at Solventum, we never stop solving for you. The Impact You’ll Make in this Role As a Regulatory Affairs & Compliance Manager, you will have the opportunity to tap into your curiosity and collaborate with some of the most innovative and diverse people around the world. Here, you will make an impact by: Reporting into the Asia EXPORT RA Leader you will be responsible for the Regulatory Affairs & Compliance for India region, including to support Solventum distributors for India and Sri-Lanka. The job holder will represent Solventum India region in all official communications and issues with health care regulatory authorities. Successful execution in this role is key to perform the effective and efficient operations of the regulatory and compliance to mainly manage import/export health care businesses and directly related to safeguard Solventum free from regulatory risk and improve the long-term financial performance for India region. Job Role includes: Hold Regulatory Affairs accountable in all pre-market registration and post-market surveillance to ensure all business and regulatory activities to meet India and sub-countries’ regulatory requirement. Develop and execute the registration submission plans and regulatory projects to support health care business. Sense and monitor the local regulations to ensure Solventum India region ahead of changes and manage the impacts. Advocate the regulatory policy change to align with international standard and harmonization to reduce the regulatory barrier and support effective work. Remain good rapport with regulatory authority and health care industry to assure the industry teamwork and partnership to support regulators’ initiative for global harmonization. Serve as an active member in regional RAC team, interacting regularly with the business and function stakeholders to ensure the organizational goals achieved to support business growth. Develop and follow the standard operating procedures to streamlines the operational process and communication flow. Manage and support the RA work owned by consultant or distributor to ensure the diligent work to support business plans. Proactively communicate with all stakeholders and establish good rapport with regional and country stakeholders to align with the business and RA goals. Demonstrate the leadership behavior if significant deviation happens that may impact compliance status or significant business risk. Support market access activity and liaise the communication with NPAA to support business pricing strategy. Your Skills and Expertise To set you up for success in this role from day one, Solventum requires (at a minimum) the following qualifications: Bachelor of Science or Biomedical Engineering related Relevant Experience in Medical Device regulatory experience required Around 5-8 years of working experiences in a function related to regulatory affairs from healthcare industry. About 2 to 3 years of leadership experiences to support business growth, preferable from medical device industry. Strong Knowledge of regulatory managements in medical device product registration and total life cycle management. Strong electronic system management skills to manage the regulatory data and plans and capability to hand-on and project management Independent and proactively working on business solution Strong communication and inter-personal skills Solventum is committed to maintaining the highest standards of integrity and professionalism in our recruitment process. Applicants must remain alert to fraudulent job postings and recruitment schemes that falsely claim to represent Solventum and seek to exploit job seekers. Please note that all email communications from Solventum regarding job opportunities with the company will be from an email with a domain of @solventum.com . Be wary of unsolicited emails or messages regarding Solventum job opportunities from emails with other email domains. Please note: your application may not be considered if you do not provide your education and work history, either by: 1) uploading a resume, or 2) entering the information into the application fields directly. Solventum Global Terms of Use and Privacy Statement Carefully read these Terms of Use before using this website. Your access to and use of this website and application for a job at Solventum are conditioned on your acceptance and compliance with these terms. 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