Job Information
Medtronic Senior Regulatory Affairs Specialist in Nanakramguda, India
At Medtronic you can begin a life-long 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
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. Responsible for coordination with other Geographies for International Regulatory Submissions, License Renewals and annual registrations
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
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
Keeps abreast of regulatory procedures and changes.
May direct interaction with regulatory agencies on defined matters.
Recommends strategies for earliest possible approvals of clinical trials applications.
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.
Required Knowledge and Experience
Bachelor’s 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.
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area.
Communicates primarily and frequently with internal contacts. Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision making
Nice to Haves
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
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 90,000+ 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 (http://www.medtronic.com)
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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 90,000+ 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.
We change lives . Each team member, each day, helps to improve and redefine how the world treats the most pressing health conditions, from heart disease to diabetes. Our industry leadership comes from the passion and ingenuity of our people. That’s who we are. Working alongside one another, we use science, medicine, and a profound understanding of the human body to build extraordinary technologies that can transform lives.
We build extraordinary solutions as one team . With one Medtronic Mindset defining how we work. Speed and decisiveness run through our DNA. Diverse perspectives inspire our bold answers to any challenge that comes our way. And we deliver results the right way, breakthrough after patient breakthrough.
This life-changing career is yours to engineer . By bringing your ambitious ideas, unique perspective and contributions, you will…
Build a better future, amplifying your impact on the causes that matter to you and the world
Grow a career reflective of your passion and abilities
Connect to a dynamic and inclusive culture that welcomes the challenge of life-long learning
These commitments set our team apart from the rest:
Experiences that put people first . Respect for people is the hallmark of our humanity. It fuels our team to positively impact even a single life. And it means we put our people first at Medtronic as well, creating a culture of belonging and always pushing to get you the career-building resources you need.
Life-transforming technologies . No matter your role, you contribute to technologies that transform lives. What we build empowers patients to live life on their terms.
Better outcomes for our world . Here, it’s about more than the bottom line. Our Mission to improve human welfare drives us. We advance healthcare, society, and equity with every design, inside and outside our walls.
Insight-driven care . Fresh viewpoints. Cutting-edge AI, data, and automation. You're shaping the future of healthcare technology and defining the next generation of breakthroughs in care
It is the policy of Medtronic to provide equal employment opportunity (EEO) to all persons regardless of age, color, national origin, citizenship status, physical or mental disability, race, religion, creed, gender, sex, sexual orientation, gender identity and/or expression, genetic information, marital status, status with regard to public assistance, veteran status, or any other characteristic protected by federal, state or local law. In addition, Medtronic will provide reasonable accommodations for qualified individuals with disabilities.
For sales reps and other patient facing field employees, going into a healthcare setting is considered an essential function of the job and we expect our employees to comply with all credentialing requirements at the hospitals or clinics they support.
This employer participates in the federal E-Verify program to confirm the identity and employment authorization of all newly hired employees. For further information about the E-Verify program, please click here (https://www.e-verify.gov/employees) .
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