Regulatory Affairs Specialist at Medtronic! Pharma Apply Online
Medtronic, a global leader in medical technology and healthcare innovation, is looking for a Regulatory Affairs Specialist to join its Gurgaon team. If you have 3–6 years of regulatory experience in the medical devices, pharmaceutical, or life sciences industry—with strong knowledge of CDSCO, FDA, CE, and design control processes—this is your opportunity to join a purpose-driven organization that improves lives worldwide.
Responsibilities for Regulatory Affairs:
- 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 as Regulatory Affairs.
- 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 for Regulatory Affairs.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 as Regulatory Affairs.
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 for Regulatory Affairs:
- 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 preferred for Regulatory Affairs.
- 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
Role for Regulatory Affairs:
- 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 as Regulatory Affairs
- Self-motivated and positive “Can do” attitude. Can work autonomously but is also a team player
Physical Job Requirements
The above statements are intended to describe the general nature and level of work being performed by employees assigned to this position, but they are not an exhaustive list of all the required responsibilities and skills of this position.
Benefits & Compensation
Medtronic offers a competitive Salary and flexible Benefits Package
A commitment to our employees lives at the core of our values. We recognize their contributions. They share in the success they help to create. We offer a wide range of benefits, resources, and competitive compensation plans designed to support you at every career and life stage.
Keywords: Medtronic, regulatory affairs specialist, job posting, Gurgaon, pharma, medical device, life science
