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Vaga de Quality Specialist
Philips em Blumenau - SC

Descrição da Vaga

Quality Specialist

Works, as a Quality Design Control for EMR BU

Key Areas of Responsibility

Providing strategic input during product creation process and contributing to the department;

Advising internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives;

Developing and preparing product registration submissions for the US, EU, China, LATAM and select worldwide locations;

Reviewing and validating marketing and labeling materials;

Maintaining existing regulatory filings/licenses;

Reviewing development quality reports and plans to ensure that the information required for submissions is adequate;

Participating in maintaining the Quality Management System for the Regulatory related processes.

Your Team

Located in Brazil/India/EU, you will work as a team member of the Quality and Regulatory team of the EMR business. For you daily activities you will report to the EMR Q&R lead and will work closely together with many internal departments such as Marketing, R&D and Medical Affairs.

Skills and Experience

Bachelors/Master of Science degree in a software, technical, or biomedical discipline

Minimum of 3-5 years of experience in (software) medical device regulated environment

Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide

Knowledge of ISO 13585 and IEC 62304 standards

Excellent working knowledge of medical device regulations, US/FDA law, MDD, other global laws and regulations

Experience in supporting international registrations and clinical evaluations/investigations (preference)

Strong background in Design Controls.

Excellent verbal and written communication skills (English)

Enthusiastic, self-motivated regulatory professional

Good communicator and team player who is able to work in a flexible and goal oriented environment

**Please, resumes only in English.*

Works, as a Quality Design Control for EMR BU

Key Areas of Responsibility

Providing strategic input during product creation process and contributing to the department;

Advising internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, Agency/industry initiatives, etc. to ensure regulatory strategy is in alignment with company objectives;

Developing and preparing product registration submissions for the US, EU, China, LATAM and select worldwide locations;

Reviewing and validating marketing and labeling materials;

Maintaining existing regulatory filings/licenses;

Reviewing development quality reports and plans to ensure that the information required for submissions is adequate;

Participating in maintaining the Quality Management System for the Regulatory related processes.

Your Team

Located in Brazil/India/EU, you will work as a team member of the Quality and Regulatory team of the EMR business. For you daily activities you will report to the EMR Q&R lead and will work closely together with many internal departments such as Marketing, R&D and Medical Affairs.

Skills and Experience

Bachelors/Master of Science degree in a software, technical, or biomedical discipline

Minimum of 3-5 years of experience in (software) medical device regulated environment

Experience with successful preparation and submission of 510(k) or international documents for registration and/or marketing of medical devices worldwide

Knowledge of ISO 13585 and IEC 62304 standards

Excellent working knowledge of medical device regulations, US/FDA law, MDD, other global laws and regulations

Experience in supporting international registrations and clinical evaluations/investigations (preference)

Strong background in Design Controls.

Excellent verbal and written communication skills (English)

Enthusiastic, self-motivated regulatory professional

Good communicator and team player who is able to work in a flexible and goal oriented environment

**Please, resumes only in English.*

Leia mais

Avaliações da Philips


Satisfação geral dos funcionários

3.89
  • Remuneração e benefícios
    3.80
  • Oportunidade de carreira
    3.20
  • Cultura da empresa
    3.85
  • Qualidade de vida
    3.67

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