Regulatory Affairs Manager - Gurgaon

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.