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Regulatory Affairs Specialist - Colombo

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Regulatory Affairs
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19000JGX Requisition #
Thanks for your interest in the Regulatory Affairs Specialist - Colombo position. Unfortunately this position has been closed but you can search our 422 open jobs by clicking here.

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 5-7 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 Sri Lanka with respect to medical device registration, import, clinical trials, etc.

·         Knowledge in application of NMRA, 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

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The mission to improve access to healthcare globally is something we are all very proud to work hard toward achieving. Great people, fun atmosphere, big city salaries. The CEO is fantastic - he is a very clear communicator of the mission and is truly dedicating his life to achieving it.
Smart and committed coworkers. Mission driven. Good benefits. Good long term career opportunities. Company is large enough that you can always find interesting projects to work on.
Knowing that everyday your work helps to save lives makes it great place to work. Training on lean practices, quality and other. Excellent peers.

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