Quality and Regulatory Affairs

Qualidade
Data inicial Início imediato
Lugar Pune, Índia.
TIPO DE CONTRATO Contrato permanente
Candidate-se agora

Na ARaymond, criamos sistemas de fixação e montagem de ponta para as máquinas e produtos que mantêm o mundo em movimento.

Fundada em Grenoble em 1865, e ainda sediada na cidade até hoje, somos um negócio familiar com uma história orgulhosa de inovação – incluindo a invenção do botão de pressão.

Os valores humanos têm impulsionado o nosso sucesso há mais de 158 anos, enraizado pelo nosso modelo de gestão de liderança servidora que capacita os colaboradores e coloca o seu bem-estar em primeiro lugar.

Hoje empregamos mais de 8.500 colaboradores em 25 países em todo o mundo. E estamos empenhados em sermos líderes em sustentabilidade para o mercado global de fixação e montagem.

Conectar as partes que mantêm o mundo em movimento

Trabalhar em um ambiente limpo, verde e produzindo alta tecnologia, você vai ajudar a construir sistemas de fixação e montagem de ponta para as inovações diárias das quais todos nós dependemos.  

Função e Responsabilidades
  • Write, analyze, and edit technical documents to support country specific regulatory submissions and compile submissions in a format consistent with applicable guidance documents, including investigational device submissions in USA, Canada, Europe and India. 
  • Work with other departments and communicate the submission requirements when documents are needed for regulatory submission. 
  •  Maintain regulatory files. 
  • Maintain and update regulatory authorizations, such as IDEs, 510(k)s, Canadian medical device licenses, and CE dossiers for EU, NRTL certifications etc. 
  • Maintain Compliance with respect to Combination products and 21CFR Part 820
  • Assure that appropriate maintenance of registrations occurs including renewals, device listings, site registrations, supplements for changes and annual reports. 
  • Support approval in other regions as required. 
  •  Assist in preparing response to regulatory authorities questions within assigned timelines.
  •  Stay abreast of regulatory procedures and changes in regulatory climate. 
  •  Assess device related incidents/complaints for medical device reporting requirements.
  •  Compile and submit reportable events to relevant regulatory authorities in timely manner. 
  • Handle recalls and field actions, if required. 
  •  Review and create product labels and review promotional material for compliance with applicable regulations and technical standards. 
  •  Support external regulatory agency audits, providing regulatory input to minimize potential for findings of non-compliance. 
  •  Assist in preparing clinical trial site ethics review board applications for investigational device trials. Prepare interim or final reports for trial site ethics boards as required 
  • Other duties as assigned.

Key Attributes

  • Self & Team Management
  • Minimum of 2 years regulatory or equivalent experience within a device or pharmaceutical company, CRO, or similar organization 
  • Scientific knowledge, must be able to digest complex data while keeping the big picture through good analytical skills 
  •  Excellent written and Verbal communication skills with the ability to listen, articulate and advocate 
  •  Proactive, high performance, result oriented and manage projects with ethical integrity
  •  Technical system skills (e.g. MS office applications, databases, efficient online research) 
  • Manage multiple projects and deadlines 
  • Ability to identify compliance risks and escalate when necessary 
  • Demonstrate both creative and critical thinking skill

    ISO 27K-

  • Maintaining awareness and adherence about applicable information security policies and procedures
  • Maintaining compliance with contractual requirements
  • Ensuring information, they use or information under their custody is adequately protected as per ARaymond information security expectations.
  • Reporting any noted suspicious behavior, vulnerability, and incidents to authority
Educação e experiência

Graduation/ Post Graduation in with Specialization in Pharma/ Engineering along with 15- 20 Years of experience

Skills

 

  • Knowledge of 5S methodology
  • Team-Working
  • Environment, Health, and Safety Risk Management
  • Customer Service Orientation
  • Workplace Emergency Preparedness
  • Decision Making
  • Knowledge of EHS Standards and Procedures
  • Communication Skills
  • Knowledge of ergonomic working conditions
  • Accountability and Ownership
  • Root cause analysis
  • Knowledge of Plastic Raw Material
  • Knowledge of Steel Raw Material

     

Candidate-se agora