New job Regulatory Affairs Specialist in Haryana
Regulatory Affairs Specialist
Company : Medtronic
Salary : Details not provided
Location : Haryana
Career 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 the Indian Sub-Continent (India, Sri Lanka, Bangladesh, Nepal)
- Coordination with global regulatory teams, local BU & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Indian Sub-Continent.
- 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 Indian Sub-Continent
Must Have: Minimum Qualifications:
- 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, Sri Lanka, Bangladesh & Nepal 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
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.
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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role. (AD