Senior Regulatory Affairs Specialist

Let’s Talk About The Team And You

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.