Job title: Regulatory Affairs Manager – Gurgaon

Company: Medtronic

Job description: Careers that Change Lives:

Make an impact on your community and the lives of others by bringing back the smiles on the faces of human beings suffering from Coronary Vascular disease. Use your passion of sales and relationship building to engage the customers and provide excellent customer service.

Lead, mentor and guide a team to drive sales in the northwest region successfully.

A Day in the life:

– Works closely with Regional, Country, and Global teams to drive new registrations and maintain registrations:

– Defines, communicates, and implements regulatory strategies and plans.

– Manages the development, submission, and maintenance of registration dossiers. Oversees the authorship and publication of submissions.

– Manages regulatory registration data to reduce registration cycle times through Speed to Market initiatives. Provides reports on registration status and cycle times.

– Understands and influences local medical device regulatory environment by leveraging key relationships with regulatory authorities and industry groups. Participates in working groups.

– Interprets and applies local regulations to business practices and provides regulatory input, advice, and guidance to the organization. Keeps all areas of Medtronic informed of regulatory requirements and emerging issues which may affect the registration approval of products.

Responsible for Regulatory Compliance, which includes:

– Oversees review of labeling and promotional materials, including relevant internet activities and publications to comply with all relevant internal policies/procedures and local country regulations.

– Coordinates with Regional QA/Regulatory Compliance Leader on Quality field actions & PMS

Responsible for Compliance, which includes:

– Coordinates with Legal and Compliance in maintaining and disseminating updated compliance policies and procedures through training of local teams.

– Works with Legal and Compliance to resolve compliance issues (communicates local issues and supports Regional/Global compliance efforts).

– Leads compliance sessions to address compliance issues and discuss plans to mitigate compliance risk; executes on plans.

Plans and manages Regulatory Affairs/Quality budget, resources, and projects. Responsible for oversight and prioritization of departmental tasks and projects. Directs and oversees the work of regulatory professionals, including training, mentoring, and professional development.

Must Have: Minimum Requirements:

• Master’s Degree in life sciences, technical or engineering or related field degree
• Minimum 10 years of experience in Regulatory Affairs capacity
• Experience in the areas of Medical Devices, IVD and biologicals and Combination products regulations is strongly preferred
• A combination of education and experience may be considered

Nice to Have:

• Strong writing and communication skills, ability to communicate effectively at multiple levels, including with regulatory authorities
• Competent English Language skills ( Reading, Writing, Listening and Speaking)
• Knowledge of medical device products and regulations and ability to interpret them
• Ability to lead a team, influence others and handles increasing levels of responsibility
• Ability to build relationships with other areas of the organization (i.e. marketing, research )
• Ability to identify and assess business risks to develop regulatory strategies
• Ability to manage/supervise employees
• Responsible, professional, detail oriented
• Strong computer skills

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.

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 or local HR to understand the Work Conditions and Physical requirements that may be specific to each role.

Additional Information

• Posting Date: Jun 1, 2022
• Travel: Yes,

Expected salary:

Location: Gurgaon, Haryana

Job date: Fri, 03 Jun 2022 02:17:55 GMT

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