Regulatory Affairs Specialist- Gurgaon

A Day in the Life 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 Responsibilities may include the following and other duties may be assigned.

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, 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.

SPECIALIST CAREER STREAM: Typically an individual contributor with responsibility in a professional discipline or specialty. Delivers and/or manages projects assigned and works with other stakeholders to achieve desired results. May act as a mentor to colleagues or may direct the work of other lower level professionals. The majority of time is spent delivering and overseeing the projects - from design to implementation - while and adhering to policies, using specialized knowledge and skills normally acquired through advanced education. DIFFERENTIATING FACTORS Autonomy: Established and productive individual contributor.
Works independently with general supervision on larger, moderately complex projects / assignments. Organizational Impact: Sets objectives for own job area to meet the objectives of projects and assignments.
Contributes to the completion of project milestones .
May have some involvement in cross functional assignments. Innovation and Complexity: Problems and issues faced are general, and may require understanding of broader set of issues or other job areas but typically are not complex .
Makes adjustments or recommends enhancements in systems and processes to solve problems or improve effectiveness of job area. Communication and Influence: Communicates primarily and frequently with internal contacts .
External interactions are less complex or problem solving in nature.
Contacts others to share information, status, needs and issues in order to inform, gain input, and support decision-making. Leadership and Talent Management: May provide guidance and assistance to entry level professionals and / or employee in Support Career Stream.

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 3-6 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

Benefits Compensation

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 RD 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