Regulatory Affairs Specialist Ii

At Medtronic you can begin a life-long career of exploration and innovation while helping champion healthcare access and equity for all Youll lead with purpose breaking down barriers to innovation in a more connected compassionate world A Day in the Life Collaborate and partner with Design QA R D Sustaining Engineering Clinical Affairs Marketing and Operations Supports the Global Operating Unit Regulatory Affairs function as the local representative for ensuring requirements are met Responsible for supporting the needs of the MEIC with regulatory support for research and development activities and ensuring Indian and other applicable regulations and policies are met Supporting Design and Development Control activities with regulatory requirements direction tactics and strategies and working in a team environment with all organizational departments Responsibilities may include the following and other duties may be assigned Prepare review file and support premarket documents for global registrations for assigned projects Collaborate with business unit and international regulatory affairs personnel to support marketing authorizations for assigned projects Represent Regulatory Affairs as team member of product development projects from Concept through Commercialization Review pre-clinical and clinical protocols and associated reports to be used in submissions for assigned projects Develop Regulatory Strategies for new or modified products for assigned projects Monitor and provide information pertaining to impact of changes in the regulatory environment Communicate with regulatory agencies and or notify bodies on administrative and routine matters Document consolidate and maintain oral and written communication with health authorities Prepare internal documents for modifications to devices when appropriate Participate in health agency inspections notified body audits as necessary Author and or review regulatory procedures and update as necessary Review change control documents and ascertain regulatory impact for external and internal documents through formal regulatory assessments Assist in development maintenance of regulatory files records and reporting systems of systematic retrieval of information Review promotional material advertising and labeling to ensure regulatory compliance on assigned projects Ensure compliance to regulations specific to clearance and approvals of MEIC developed products raw material and or prototype Required Knowledge and Experience Bachelor degree in Medical Mechanical Electric Life Science or other healthcare related majors 4-7 years experiences for RA role in medical device and or pharmaceutical industry Good understanding for regulations and policies issued by India US FDA and EU and ability to interpret international regulatory requirements Excellent written organizational and communication skills is required and have a flexible and team-oriented attitude Strong attention to details and ability to handle multiple tasks good at planning and can work under pressure Good at English including reading writing and speaking Good Learning attitudePhysical Job RequirementsThe above statements are intended to describe the general nature and level of work being performed by employees assigned to this position but they are not an exhaustive list of all the required responsibilities and skills of this position Benefits CompensationMedtronic offers a competitive Salary and flexible Benefits Package A commitment to our employees lives at the core of our values We recognize their contributions They share in the success they help to create We offer a wide range of benefits resources and competitive compensation plans designed to support you at every career and life stage About MedtronicWe lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions Our Mission xe2x80x94 to alleviate pain restore health and extend life xe2x80x94 unites a global team of 90 000 passionate people We are engineers at heartxe2x80x94 putting ambitious ideas to work to generate real solutions for real people From the R D lab to the factory floor to the conference room every one of us experiments creates builds improves and solves We have the talent diverse perspectives and guts to engineer the extraordinary Learn more about our business mission and our commitment to diversity