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Regulatory Affairs Specialist

🔍 Gurgaon, Haryana, India

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Regulatory Affairs
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16000N6X 招聘登记表编号
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Dec 07, 2016 发布日期
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Qualifications & Experience:

 

·         B Pharm / M Pharm / Bachelor or Master Degree in Bio-Medical Engineering / Science discipline with training in Regulatory Affairs

·         Must have at least 4-6 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, 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

 

Attributes:

·         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

 

KEY TRAITS

 

           TRAITS

STRONG INDICATORS

External Focus

·         Interacts regularly with customers and seeks inputs.

·         Well informed regarding market and industry / competitors operating in territory.

·         Initiates or champions changes from the outside in.

·         Explores new opportunities and asks informed questions.

·         Experience of dealing with various functions internally and externally

Execute

·         Consistently delivers results on time and exceeds expectations.

·         Ensures the processes are capable of achieving the desired  direction

·         Clarifies roles and aligns resources allowing for faster execution.

·         Orchestrates resources for optimal use. Continually monitors progress and seeks continuous improvement.

Inspires Others

·         Has the ability to connect ,motivate, engage the sales force

·         Builds networks to obtain cooperation without relying on authority.

·         Makes active attempts to influence events to achieve goals

·         Establishing procedures to monitor the results of delegations, assignments, or projects;

·         Seeks and values different perspectives and ideas to foster an inclusive work environment 

Clear Thinking

·         Understands strategic contexts,  identifies opportunities

·         Is able to anticipate risks, evaluate options  and defines priorities for the team

·         Establishing a course for self and for others to accomplish a specific goal; planning proper assignments of personnel and appropriate allocation of resources.

·         Committing to an action after developing alternative courses of action that are based on logical assumptions and factual information and that take into consideration the resources, constraints and organizational values.

Mission values
  • Derived from the Mission
  • Ensures compliance and quality in everything we do at Medtronic

Compliance & Integrity
  • Models the highest standards of honesty, ethics, and integrity.   
  • Consistently promotes and adheres to letter and spirit of Medtronic Code of Conduct, all applicable laws, and company policies.
  • Promotes  and ensures an environment where ethical behavior is expected and
  • unethical behavior is not tolerated
  • Expeditiously takes appropriate  action when problems occur

 

* * * * *

我的概要信息

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工程部门

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销售

为有需求的人们提供改变他们生活的解决方案。从工作中取得应有的回报。

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监管

接受我们的挑战，让全球医疗服务的价格更加廉宜，让更多的人能够享受医疗服务。你的洞察力和观点将帮助我们创造出能够改变世界的解决方案。

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了解 MEDTRONIC 的使命。

我们的使命是 “减轻病痛、恢复健康及延长寿命” 这不仅仅是一句口号。这是我们的员工每天赖以生存的信仰。

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员工故事：
工程部门

Alyse是神经调控部门的工程项目经理，工作地点在明尼苏达州明尼亚波利斯市。

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“我们努力工作，致力于在全球范围内扩大医疗服务的受众群体，对此我们感到十分骄傲。出色的员工、愉悦的氛围、有竞争力的薪资。首席执行官是一位伟大的人物－他明确地践行着这一使命，并且全身心地投入到他的生活和工作中，只为实现这一目标。”
“聪明又承担义务的同事。使命驱动力。良好的福利。良好的长期职业机会。你始终可以在公司里发现有趣的项目并投身其中。”
“这里是一个非常好的工作场所，因为你知道自己每天所做的工作都将挽救人们的生命。在精益实践、质量和其他方面的培训。出色的同事。”

在 MEDTRONIC 工作

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Beginning September 30, 2021, Medtronic requires new hires to provide proof of vaccination against COVID-19 as of their start date. This requirement is a condition of employment at Medtronic and it applies to U.S. employees as of their start date. For access to office sites, if proof of vaccination is not provided a COVID-19 test is required every three days. For patient facing field employees, vaccination may be a requirement of the employment. If you are unable to receive the vaccine due to a health condition or because it is prohibited as a result of your sincerely held religious beliefs, you will have an opportunity to request a reasonable accommodation.

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