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Regulatory Affairs Specialist - Colombo

📁
Regulatory Affairs
📅
19000JGX Requisition #
Careers that Change Lives

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 in Sri Lanka. He/ she will be responsible for providing technical support by interpreting federal and local regulations as they apply to products, processes, practices and procedures.  

 

Key Accountabilities:

·         Manage, plan and execute the preparation, review and submission of dossiers for product registrations, import licenses and other approvals from regulatory agencies (registrations and renewals) thereby supporting the business units and supply chain management in compliance with regulatory requirements in the Indian Sub-Continent (Sri Lanka)

·         Coordination with distributers for all BU’s in Sri Lanka for submission and approval from NMRA and maintaining Regulatory compliance.

·         Coordination with global regulatory teams, local BU, India RA team & other functions, for regulatory strategies and all documentation support required for regulatory submissions in Sri Lanka.

·         Submit and track registration/re-registration applications with the authorities.

·         Liaise with product divisions and obtain relevant details for filing changes to the approved products/licenses.

·         Assess the Change controls from the product divisions through post approval change management and continuously ensure regulatory compliance (reporting of adverse events/field actions, etc.).

·         Understanding & interpretation of law & the local regulatory requirement and implementing same in submission with compliance.

·         Close monitoring of any changes in local & global regulations and communicating same within the department and respecting & following all SOP / system implemented within the department and organization.

·         Ensure business continuity through regulatory filings, obtaining regulatory approvals and continuously ensuring regulatory compliance.  Also ensure continuous implementation of the Quality Management System in Sri Lanka.

  • Supporting the Marketing Teams on Tender related issues
  • Development, implementation and maintenance of regulatory systems pertaining to regulatory document management (SOP's, archival, trackers and systems) within the department and organization.

·         Interface and coordinate with regulatory agencies/competent authorities in Sri Lanka with respect to submissions, obtaining registrations/licenses, amendments, regulatory compliance, packaging, quality control testing or release, etc.

·         Work with clinical team on submission and approval of clinical trials applications (clinical trial approvals, import licenses/test licenses for clinical trial, amendments, etc.) from various regulatory agencies in the Indian Sub-Continent

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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