Love Mondays


Vaga de Regulatory Affairs Specialist
Philips em Blumenau - SC

Descrição da Vaga

Regulatory Affairs Specialist

Job Description Summary

Works, as a Regulatory Affairs Specialist for EMR BU. This position covers the following activities:

Plan, generate, and coordinate regulatory submissions for product licensing;

Review and approve product labeling and product-related marketing communications;

Maintain existing regulatory filings/licenses;

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

Implement global regulatory plans through understanding the competitive market landscape and product marketing strategy.

Key Areas of Responsibility

Developing and implementing global regulatory strategy and roadmaps for new products and product changes through deep understanding of the regulatory market landscape, regulatory / legislative initiatives, and product marketing strategy;

Providing strategic input during product creation process and contributing to the department’s overall regulatory strategy plan;

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

An international team of Regulatory Affairs Specialists striving for the best regulatory compliance. You will report to the Regulatory Affairs Manager of Healthcare Informatics. 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)

Extensive experience in performing regulatory activities such as writing Technical Files, reviewing documentation for regulatory compliance, working with international regulatory agencies as well as with EU notified bodies

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

Job Description Summary

Works, as a Regulatory Affairs Specialist for EMR BU. This position covers the following activities:

Plan, generate, and coordinate regulatory submissions for product licensing;

Review and approve product labeling and product-related marketing communications;

Maintain existing regulatory filings/licenses;

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

Implement global regulatory plans through understanding the competitive market landscape and product marketing strategy.

Key Areas of Responsibility

Developing and implementing global regulatory strategy and roadmaps for new products and product changes through deep understanding of the regulatory market landscape, regulatory / legislative initiatives, and product marketing strategy;

Providing strategic input during product creation process and contributing to the department’s overall regulatory strategy plan;

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

An international team of Regulatory Affairs Specialists striving for the best regulatory compliance. You will report to the Regulatory Affairs Manager of Healthcare Informatics. 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)

Extensive experience in performing regulatory activities such as writing Technical Files, reviewing documentation for regulatory compliance, working with international regulatory agencies as well as with EU notified bodies

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

Leia mais

Avaliações da Philips


Satisfação geral dos funcionários

3.82
  • Remuneração e benefícios
    3.56
  • Oportunidade de carreira
    3.19
  • Cultura da empresa
    3.59
  • Qualidade de vida
    3.66

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