Regulatory Affairs Specialist - II
Regulatory Affairs Specialist - II
Posted on :
06-02-2025
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1 Vacancy
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Job Description
Job Title: Regulatory Affairs Specialist II
Job Location: Hyderabad Telangana India
Job Location Type: Hybrid
Job Contract Type: Fulltime
Job Seniority Level: Associate
At Medtronic you can begin a lifelong career of exploration and innovation while helping champion healthcare access and equity for all. You’ll lead with purpose breaking down barriers to innovation in a more connected compassionate world.
A Day in the Life
Regulatory Affairs SpecialistII
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers awardwinning programs to accelerate your development and growth. Our size scope and market leadership give you the chance to explore career opportunities — and grow as we grow.
Careers that Change Lives
Supporting Design and Development Control activities with regulatory requirements direction tactics and strategies and working in a team environment with all organizational departments.
Together 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.
Let’s 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 Requirements
The 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 & Compensation
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.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain restore health and extend life — unites a global team of 90000 passionate people.
We are engineers at heart— 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 here
A Day in the Life
Regulatory Affairs SpecialistII
Career growth and development is about learning and stretching yourself to grow your expertise and navigate your career. Medtronic offers awardwinning programs to accelerate your development and growth. Our size scope and market leadership give you the chance to explore career opportunities — and grow as we grow.
Careers that Change Lives
Supporting Design and Development Control activities with regulatory requirements direction tactics and strategies and working in a team environment with all organizational departments.
- 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.
- Review preclinical 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.
- 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 product’s raw material and/or prototype.
- Bachelor degree in Medical Mechanical Electric Life Science or other healthcare related majors
- 47 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 teamoriented 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 attitude
- US and global regulatory affairs knowledge and experience.
- Experience working with crossfunctional 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 detailoriented 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 wellversed within the regulatory landscape.
- RAPS Regulatory Affairs Certification (RAC).
Together 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.
Let’s 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 Requirements
The 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 & Compensation
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.
About Medtronic
We lead global healthcare technology and boldly attack the most challenging health problems facing humanity by searching out and finding solutions.
Our Mission — to alleviate pain restore health and extend life — unites a global team of 90000 passionate people.
We are engineers at heart— 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 here
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Employment Type
Full Time
Key Skills
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