Current jobs related to Regulatory Affairs Associate II - Birmingham, Birmingham - Thermo Fisher Scientific

  • Regulatory Affairs Specialist II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    3 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    3 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Title: Regulatory Affairs Specialist IIThe Regulatory Affairs Specialist II plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our Global RA team. The successful candidate will be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac.Key ResponsibilitiesInterpret local regulatory requirements and prepare submission documentation to ensure...

  • Regulatory Affairs Specialist II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist II to join our Global RA team. The successful candidate will be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac.Key ResponsibilitiesInterpret local regulatory requirements and prepare submission documentation to ensure...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryThe Regulatory Affairs Specialist II will work in the Global RA team and be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This role involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.Key...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryThe Regulatory Affairs Specialist II will work in the Global RA team and be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.Key ResponsibilitiesAuthor,...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryThe Regulatory Affairs Specialist II will work in the Global RA team and be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This role involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.Key...

  • Regulatory Affairs Specialist II

    1 month ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job SummaryThe Regulatory Affairs Specialist II will work in the Global RA team and be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.Key ResponsibilitiesAuthor,...

  • Regulatory Affairs Specialist II

    2 months ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Summary:The Regulatory Affairs Specialist II will work in the Global Regulatory team at Thermo Fisher Scientific, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This role involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    2 months ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    Job Summary:The Regulatory Affairs Specialist II will work in the Global Regulatory team at Thermo Fisher Scientific, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This role involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to...

  • Regulatory Affairs Specialist II

    2 months ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    {"Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Global RA team. The successful candidate will be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac.Key Responsibilities* Interpret local regulatory requirements and prepare submission documentation* Track and...

  • Regulatory Affairs Specialist II

    2 months ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    {"Job SummaryWe are seeking a highly skilled Regulatory Affairs Specialist to join our Global RA team. The successful candidate will be responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac.Key Responsibilities* Interpret local regulatory requirements and prepare submission documentation* Track and...

  • Regulatory Affairs Specialist II

    5 days ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    The Regulatory Affairs Specialist at Thermo Fisher Scientific works in the Global RA team and is responsible for the registration of PDx products in global markets including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.A Day in the...

  • Regulatory Affairs Specialist II

    7 days ago

    Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

    The Regulatory Affairs Specialist at Thermo Fisher Scientific plays a critical role in the Global RA team, responsible for the registration of PDx products in global markets, including EMEA, USA, LATAM, and AsiaPac. This involves interpreting local regulatory requirements, preparing submission documentation, and tracking registrations to completion.A Day in...

  • Clinical Research Associate II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Pharmiweb Full time

    Job Title: Clinical Research Associate IISyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and patient to the center of everything we...

  • Clinical Research Associate II

    4 weeks ago

    Birmingham, Birmingham, United Kingdom Pharmiweb Full time

    Job Title: Clinical Research Associate IISyneos Health is a leading biopharmaceutical solutions organization that accelerates customer success. We translate unique clinical, medical affairs, and commercial insights into outcomes to address modern market realities.Our Clinical Development model brings the customer and patient to the center of everything we...

Regulatory Affairs Associate II

2 months ago

Birmingham, Birmingham, United Kingdom Thermo Fisher Scientific Full time

The Regulatory Affairs Specialist plays a crucial role within the Global Regulatory Affairs team, focusing on the registration of products in various international markets, including EMEA, USA, LATAM, and AsiaPac. This position involves understanding and interpreting local regulatory standards, preparing necessary submission documents, and ensuring that registrations are completed successfully.

Responsibilities:

  • Develop, compile, and submit registration documentation to ensure compliance with regional regulations.
  • Maintain and track files for annual licenses, registrations, and listings with relevant Regulatory Authorities.
  • Gather, analyze, and apply local regulatory intelligence and related information through active participation in industry associations.
  • Review and approve change requests to ensure adherence to compliance and regulatory submission requirements.
  • Serve as the Regulatory representative on project teams, offering regulatory insights and guidance.
  • Assist in external and internal site audits, conduct regulatory assessments, and ensure alignment with company policies and regulations (including MDSAP and ISO13485).
  • Foster a culture of process improvement through participation in PPI activities, aimed at enhancing the quality and efficiency of regulatory processes.

Qualifications:

Education:

  • A degree in Chemistry, Biology, Biochemistry, or a related scientific discipline is required.
  • Regulatory qualifications are considered advantageous.

Experience:

  • Demonstrated experience in a regulatory or quality-focused environment.

Skills and Abilities:

  • Familiarity with ISO13485, MDSAP, and ISO9001 standards.
  • Proven experience in preparing regulatory submission documentation.
  • Excellent interpersonal, verbal, and written communication skills.

Benefits:

We provide competitive compensation, an annual incentive plan, healthcare benefits, and a variety of employee perks. Thermo Fisher Scientific is committed to fostering an innovative and forward-thinking workplace, offering exceptional career development opportunities. Our company culture emphasizes integrity, intensity, involvement, and innovation.