Quality and Regulatory Affairs

Quality and Regulatory Affairs**QUALIDADE**

**DATA INICIAL**

Início imediato**LUGAR**

Pune, Índia.**TIPO DE CONTRATO**

Contrato permanenteNa 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.
- 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
- 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