Sr. Regulatory Affairs Specialist

Job Title Sr Regulatory Affairs Specialist - ET-HyderabadJob Location Hyderabad Telangana IndiaJob Location Type HybridJob Contract Type Full-timeJob Seniority Level Mid-Senior levelAt 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 LifeSenior Regulatory Affairs SpecialistIn this exciting role as a Senior Regulatory Affair Specialist you will have responsibility for developing and implementing compliant regulatory processes within the Regulatory organization Careers that Change LivesCareer growth and development is about learning and stretching yourself to grow your expertise and navigate your career Medtronic offers award-winning programs to accelerate your development and growth Our size scope and market leadership give you the chance to explore career opportunities xe2x80x94 and grow as we grow A Day in the LifeJob Responsibilities Process SME to ensure appropriate coordination and advise on consistent interpretation of required data attributes Keeps abreast of regulatory procedures and changes Provide requested regulatory data and documents to support tenders Lead in development maintenance of regulatory files data records and reporting systems of systematic retrieval of information 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 Preparation of document packages for international regulatory submissions from all areas of company internal audits and inspections Compiles all materials required in submissions license renewal and annual registrations Recommends changes for labelling manufacturing marketing and clinical protocol for regulatory compliance Monitors and improves tracking control systems May direct interaction with regulatory agencies on defined matters 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 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 Minimum Qualifications Bachelors degree in Medical Mechanical Electric Life Science or other healthcare related majors 7 years experiences for RA role in medical device and or pharmaceutical industry Works independently with general supervision on larger moderately complex projects assignments Contributes to the completion of project milestones Adjusts or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area Ability to quickly establish credibility with all levels of customer base Communicates primarily and frequently with internal contacts Contacts others to share information status needs and issues to inform gain input and support decision making Nice to Haves US and global regulatory affairs knowledge and experience Experience working with cross-functional teams Effective verbal and written communication skills both internally and externally Experience with solving problems and concerns Experience with project management and adherence to time schedules Work well under pressure in a dynamic environment Highly organized detail-oriented and efficient Team player who seeks to help and learn from colleagues seeing the department success as their own Ability to manage projects to completion within and outside of the direct department and company Strong interpersonal and negotiation influencing skills while maintaining a high level of professionalism Proactively seeks to develop and become well-versed within the regulatory landscape RAPS Regulatory Affairs Certification RAC About MedtronicTogether we can change healthcare worldwide At Medtronic we push the limits of what technology therapies and services can do to help alleviate pain restore health and extend life We challenge ourselves and each other to make tomorrow better than yesterday It is what makes this an exciting and rewarding place to be We want to accelerate and advance our ability to create meaningful innovations - but we will only succeed with the right people on our team Lets work together to address universal healthcare needs and improve patients lives Help us shape the future Whatever your specialty or ambitions you can make a difference at Medtronic - both in the lives of others and your career Join us in our commitment to take healthcare further together Physical 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 PackageA 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 hereLifelancer is a talent-hiring platform in Life Sciences Pharma and IT The platform connects talent with opportunities in pharma biotech health sciences healthtech and IT domains For more details and to find similar roles please check out the below Lifelancer link