Regulatory Specialist

3 weeks ago

Bengaluru, India Fourth Frontier Full time

Position Summary:


Fourth Frontier is looking for a talented, self-driven Regulatory Specialist to join our expanding team. Primarily responsible registrations and supporting compilation and authoring of technical documentation to support regulatory submissions. In addition, responsibilities will include supporting the development of the quality management system in accordance with relevant regulatory requirements for medical devices. Oversee, support, and ensure that an effective and efficient quality management system is built and maintained. Responsibility for ensuring that all

applicable quality system regulations are met in order to receive regulatory clearance/certification.


Responsibility:

  • Lead regulatory compliance with the appropriate internal and external regulatory requirements (including but not limited to FDA, ISO, EU-MDR, and individual country requirements).
  • Lead Regulatory Training coordination
  • Contribute to the development of optimum future state of QMS for business needs.

 Interpretation of ISO 13485, MDSAP and MDR

 Assisting in the identification of actions required to ensure compliance with ISO 13485, MDSAP and MDR

 Assisting in providing inputs to the project lead to ensure the creation of project plans for ISO 13485, MDSAP and MDR

 Conducting updates to labeling, SOPs, work instructions, trending tools and policy documents to ensure compliance with ISO 13485, MDSAP and MDR

 Supporting internal and external audits as required

 Supporting regulatory submissions and registrations as required

 Coordination of Standards Review Activities

  • Oversee and execute development and/or modification of Fourth Frontier QMS.
  • Support Management Review and Quality Planning Review and related forums.
  • Assess and quantify requirements for QMS requirements to optimize structure.
  • Drive GMP and GDP within Quality organization.
  • Identify and implement improvement opportunities to increase the efficiency and effectiveness of the QMS.
  • Develop and deliver training for QMS areas of expertise.
  • Contribute to the development, maintenance, and improvements of policies and procedures.
  • Implement best-in-class practices and benchmark against industry leaders and regulatory requirements.
  • Liaise and communicate with notified bodies to manage certification changes.
  • Ensure QMS reflects actual activities, business needs and supports NPD requirements.
  • Engage in relevant QMS IS discussions.
  • Basic project management understanding.
  • Key contributor to QMS business process(as) and understand IS system support requirements.
  • Support internal and external quality system audits.
  • Understands system integration.
  • Support IS change control assessment and approval.


Experience:

Minimum of 2 years’ experience in a regulated environment or equivalent preferred.


Qualifications:

Degree qualification in a Science, Engineering, Business or related discipline.


Skills:

 Excellent communication skills

 Experience in a regulated environment and interaction with regulatory agencies required.

 Some knowledge and understanding of US regs (21 CFR Part 820) and ISO 13485

 Strong knowledge of Quality Systems (CAPA, audits, Management Review, Quality Planning, etc.)

 Strong communication, project management and influencing skills.

 Ability to plan, organize, and implement multiple concurrent tasks.

 Strong interpersonal skills, written, oral communication and negotiations skills. Must demonstrate the ability to effectively communicate up/down and across different levels of the organization.

 Analytical and problem-solving capabilities with the ability to draw insights from data quickly and to define executable actions.

 Demonstrated ability to work in cross-functional team environments.

 Experience in compliance risk situations.

 Computer literacy.

 Some travel may be required.


Desirable criteria:

 Previous experience of pre-clinical and clinical investigations preferred

 Knowledge of GLP, ISO 62366 and ISO 14155 and EU-MDR

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