Job Description

Careers that Change Lives

Responsible for implementation of regulatory compliance systems and support Regulatory Affairs activities of India Medtronic. He/she participates in all activities relating to preparation, submission and follow up to obtain approvals/renewals for products and its variations & line extension indications and labeling approvals of medical devices of various business units of Medtronic. He/ she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures .


A Day in the Life

Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in India.


Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in India.


Submit and track registration/re-registration applications with the authorities.


Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.


Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).


Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.


Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.


Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance. Also ensure continuous implementation of the Quality Management System in India.


Supporting the Marketing Teams on Tender related issues


Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival, trackers and systems) within the department and organization.


Interface and coordinate with regulatory agencies/competent authorities (CDSCO, CDDA, DGDA, State FDA, DoT, AERB, etc.) with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.


Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the India


Must Have: Minimum Requirements B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs


Must have at least 5-7 years' experience in the pharma/medical device/life science industry with at least 2-3 years' medical device experience in regulatory affairs


Conversant with various regulatory requirements for India with respect to medical device registration, import, clinical trials, etc.


Knowledge in application of CDSCO, FDA, CE and other regulatory requirements especially in the area of Quality Systems and Design Control as applied to projects from design inception to manufacturing release





Nice to Have

Excellent communication and interpersonal skills - Good verbal communicator and presenter


Customer focused: Understands and delivers customer service


Ability to quickly establish credibility with all levels of Regulatory Agencies, Government, etc.


Good verbal and written communication skills in English - with colleagues, management and external authorities


Self-motivated and positive "Can do" attitude. Can work autonomously but is also a team player


Outgoing and friendly: Enthusiastic, energetic, diplomatic, willingness to learn


Be able to plan, manage, organize and report in an efficient way


Be independent, persuasive, innovative and able to summarize


Good time management: Well organized, able to set and reset priorities.


KEY TRAITS

TRAITS



STRONG INDICATORS





External Focus



Interacts regularly with customers and seeks inputs.


Well informed regarding market and industry / competitors operating in territory.


Initiates or champions changes from the outside in.


Explores new opportunities and asks informed questions.


Experience of dealing with various functions internally and externally





Execute



Consistently delivers results on time and exceeds expectations.


Ensures the processes are capable of achieving the desired direction


Clarifies roles and aligns resources allowing for faster execution.


Orchestrates resources for optimal use. Continually monitors progress and seeks continuous improvement.





Inspires Others



Has the ability to connect ,motivate, engage the sales force


Builds networks to obtain cooperation without relying on authority.


Makes active attempts to influence events to achieve goals


Establishing procedures to monitor the results of delegations, assignments, or projects;


Seeks and values different perspectives and ideas to foster an inclusive work environment





Clear Thinking



Understands strategic contexts, identifies opportunities


Is able to anticipate risks, evaluate options and defines priorities for the team


Establishing a course for self and for others to accomplish a specific goal; planning proper assignments of personnel and appropriate allocation of resources.


Committing to an action after developing alternative courses of action that are based on logical assumptions and factual information and that take into consideration the resources, constraints and organizational values.





Mission values



• Derived from the Mission
Ensures compliance and quality in everything we do at Medtronic
•


Compliance & Integrity



• Models the highest standards of honesty, ethics, and integrity.
• Consistently promotes and adheres to letter and spirit of Medtronic Code of Conduct, all applicable laws, and company policies.
• Promotes and ensures an environment where ethical behavior is expected and
• unethical behavior is not tolerated
• Expeditiously takes appropriate action when problems occur




Physical Job Requirements




The physical demands described within the Responsibilities section of this job description are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For Office Roles: While performing the duties of this job, the employee is regularly required to be independently mobile. The employee is also required to interact with a computer, and communicate with peers and co-workers. Contact your manager, recruiter or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (ADA-United States of America)
About Medtronic





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.