Senior Regulatory Affairs Specialist

16 hours ago

Delhi, Delhi, India Resmed Full time ₹ 40,000 - ₹ 80,000 per year

Let's talk about the team and you

The RA Global team is located at various offices around the world and is responsible for compliance with multiple regulatory frameworks as it relates to design, development and manufacture of products as well as services which meet our customer's requirements.

Based in New Delhi, you will manage and execute the planning, development and implementation of RA strategies for India and neighbouring countries. You  will also provide regional regulatory support to operational activities for India including label review. You will be part of and collaborate closely with other global and regional RA teams.

Let's talk about responsibilities

  • Participate in cross functional teams, by providing regulatory strategy, timelines and deliverables; working closely with clinical, marketing, and commercial functions to assure appropriate requirements are defined for the specific device/channel, including claims and target patient population within each market.

  • Develop and implement technical files and submissions to regulatory authorities and/or external partners within region of responsibility in an accurate and timely manner.

  • Manage the continuance of regulatory compliance (particularly post market) of existing ResMed products, including software as a medical device in selected region(s).

  • Review and provide feedback on country-specific advertising, including product claims as well as overall direct to consumer content.

  • Region specific due diligence on new projects, including acquisitions.

  • Support initiatives related to regional entity creations (including eCommerce).

  • Ensure timely, professional and proactive communications with internal customers to ensure transparency of the regulatory strategic plans, updates/changes and impact to projected timeframes.

  • Monitor and maintain high level of awareness on external standards that will influence our business through internal and external networks.

  • Accurately and timely share and recommended solutions on any potentially significant changes that will impact the business.

  • Provide post market regulatory support (e.g. Medical Device Reporting) and guidance as required.

Let's talk qualifications and experience

  • Min Degree in a Lifescience or Engineering related discipline.

  • Min 6 years' regulatory experience in a regional role handling regulatory work for medical devices in India and other similar entities or for other regulated products, including consumer products.

  • Experience in preparation and submission to India's Health Authority (CDSCO). Other submission experience within similar markets is also welcomed.

  • Experience in review of marketing materials for medical devices or other regulated products.

  • Strong interpersonal communication skills in English.

  • Ability to prioritize workload and work independently by being resourceful.

Joining us is more than saying "yes" to making the world a healthier place. It's discovering a career that's challenging, supportive and inspiring. Where a culture driven by excellence helps you not only meet your goals, but also create new ones. We focus on creating a diverse and inclusive culture, encouraging individual expression in the workplace and thrive on the innovative ideas this generates. If this sounds like the workplace for you, apply now

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