HYDERABAD · FULLTIME
Sr Regulatory Affairs Specialist
Medtronic
Hyderabad · onsite · Posted 4d ago
Sourced from
Undisclosed7–12 yrsfulltimeHyderabad
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Section · 01
About this role
Careers that change lives start here. Medtronic is a global leader in healthcare technology with a Mission to alleviate pain, restore health, and extend life. Our 95, 000 employees work across more than 150 countries to put patients first - developing innovative medical technologies that improve the lives of 72+ million patients each year. Your unique talents will help shape the future of healthcare while building a career grounded in purpose, growth, and impact.
A Day in the Life Supporting Design and Development Control activities with regulatory requirements, direction, tactics and strategies and working in a team environment with all organizational departments. Preparation of document packages for international regulatory submissions from all areas of company, internal audits and inspections. Responsibilities may include the following and other duties may be assigned:
- Set up new process for entering new data - Regulatory Information Management System.
- 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
- Keeps abreast of regulatory procedures and changes.
- 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.
Required knowledge and experience:
- Bachelor s degree in medical, Mechanical, Electric Life Science or other healthcare related majors.
- 7+ year s experience 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 Have Skills: - Excellent communication and interpersonal skills.
- Excellent written, organizational, and communication skills is required, and have a flexible and team-oriented attitude.
- Self-motivated and positive.
- Ability to quickly establish credibility with all levels of customer base.
Physical Job Requirements
Recruitment Fraud Alert
We are aware of phishing scams targeting job seekers. Please keep the following in mind:
Apply only through official Medtronic channels. All legitimate Medtronic recruiting communications come from approved Medtronic platforms and official @medtronic. com email addresses.
Medtronic will never ask for payment or sensitive personal information (such as bank account or Social Security details) during early stages of the hiring process. Any such requests are not legitimate.
If you receive a suspicious message claiming to be from Medtronic, do not respond, click links, or open attachments. . com .
Medtronic 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.
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.
Disclaimer: This job posting has been aggregated from external source. Role details, content, and availability are subject to change. Applicants are advised to confirm the latest information directly on the company website before applying.
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Section · 02
Skills
LIFESCIENCEauditsControl SystemsChange Controlpharmaceutical industryhealthcare technologyHealthcareCommunication SkillsManufacturingmaintenancecompliancemarketingPharmaceuticalCommunication And Interpersonal Skills
Section · Company
About Medtronic
Medtronic
Medical Equipment
850
employees
1979
47 years old
Mumbai, Maharashtra
India
About
A global healthcare technology leader — boldly attacking the most challenging health problems facing humanity with innovations that transform lives.
Industries
Medical Equipment
Employee ratings
679 reviews
3.9/ 5
Culture
3.8
Career growth
3.2
Work-life
3.8
Employees rate it well for
Work Life Balance104Work Culture82Senior Management72Salary37Career Growth36
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