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International Regulatory Affairs Officer - Advertising & Promotion

posted by: spj_bot

About the Job

Excelya is seeking an experienced International Regulatory Affairs Officer specializing in Advertising and Promotion. In this pivotal role, you will be part of a dedicated team that embodies Audacity, Care, and Energy, contributing to our mission of ensuring compliance and excellence in promotional practices across global markets.

Your expertise will drive the development and implementation of regulatory strategies for advertising and promotional materials, ensuring adherence to regulations across various international jurisdictions while aligning with our corporate goals.

Main Responsibilities:

Job Skills

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Clinical Evaluation Manager Medical Devices

posted by: spj_bot

About the Job

At Excelya, we embody the values of Audacity, Care, and Energy as we strive to develop innovative solutions in a fast-paced, collaborative environment. We are seeking a skilled Medical Writer to join our dedicated team. This role offers the opportunity to create impactful documentation that plays a crucial role in the medical research and development process.

As a Medical Writer, you will be responsible for developing high-quality, scientifically accurate, and compliant documents to support clinical studies and regulatory submissions, ensuring that the information is clear, concise, and accessible to a wide range of stakeholders.

Main Responsibilities:

Job Skills

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Medical Affairs Lead - Medical Devices

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As the Head of Medical Affairs, you will lead our efforts in shaping the medical strategy and direction for our product portfolio, ensuring that our initiatives align with our mission of advancing patient care through innovative solutions.

This position offers an exceptional opportunity to work at the intersection of science and business, leading a dedicated team while collaborating cross-functionally to achieve our goals.

Main Responsibilities

Medical & Scientific Leadership

Job Skills

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German Speaking Customer Care - Health Tech | Work In Greece

posted by: spj_bot

Join the innovative team at Mercier Consultancy MD as a German Speaking Customer Care Specialist in the Health Tech sector! In this role, you will provide essential support to German-speaking clients in a fast-growing industry, all while enjoying the scenic beauty of Greece. If you are passionate about helping others and have an interest in health technology, we want you on our team!

Key Responsibilities

  • Deliver outstanding customer service in German via phone, email, and chat, addressing inquiries related to health tech products and services.
  • Assist customers with account management, product usage, and troubleshooting technical issues.
  • Collaborate with internal teams, including technical support and product development, to resolve complex customer queries efficiently.
  • Document and maintain accurate records of customer interactions and feedback in our CRM system.
  • Monitor customer feedback and gather insights to help improve our products and services.
  • Stay informed about the latest developments in health technology and our product offerings to provide informed assistance to customers.

Requirements

Job Skills

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Regulatory Affairs Officer

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team within Regulatory Affairs. You will play a key part in ensuring compliance, supporting regulatory strategies, and enabling the successful development and maintenance of innovative health products. You’ll evolve in a stimulating professional environment that encourages personal and intellectual growth.

Main responsibilities :

Job Skills

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Regulatory Affairs Officer

posted by: spj_bot

Join Excelya as Regulatory Affairs Officer, where Audacity, Care, and Energy define who we are and how we work. We believe in creating bold solutions and fostering an inclusive environment where collaboration and individual growth go hand in hand.

This role is an exciting opportunity to contribute to a dynamic, ambitious team in Regulatory Affairs. You will play a critical part in driving innovation and making an impact in the Regulatory affairs space, while enjoying a stimulating professional environment that encourages personal and intellectual growth.

We are looking for a Regulatory Affairs Officer to join our team in Greece.

Main responsibilities :

- Preparing and submitting regulatory documentation,

- Monitoring legislation,

- Supporting product lifecycle management (Marketing Authorization licenses, Variations, Renewals, Transfers).

- Review/Perform translations of artworks, Product Information and Promotional materials.

- Contact with Authorities.

- Maintain the files and databases electronically and in hardcopy, when required.

- Follows EXCELYA and Client policies, procedures, instructions, guidance.

- Ensure data privacy requirements are met.

Requirements

About You:

At Excelya, taking audacious steps is encouraged, so we’re looking for individuals who are ready to grow with us and share our values.

Job Skills

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Regulatory Affairs Officer - Advertising & Promotional Materials

posted by: spj_bot

About the Job

Excelya is seeking a talented Regulatory Affairs Officer specializing in Advertising and Promotional Materials. At Excelya, we prioritize Audacity, Care, and Energy in our professional endeavors, supporting our mission to deliver high-quality healthcare solutions.

As a Regulatory Affairs Officer, you will play a key role in reviewing and approving promotional materials to ensure compliance with applicable regulations. You will work closely with marketing and medical teams to develop strategies that meet both compliance standards and business objectives, creating impactful messaging for our products.

Main Responsibilities:

  • Provide regulatory guidance on the promotion of pharmaceuticals and/or medical devices in France.
  • Manage the review process for promotional, institutional, and environmental materials produced by pharmaceutical companies.
  • Evaluate and approve promotional content to ensure compliance with the French Public Health Code (CSP) and the recommendations of the French National Agency for Medicines and Health Products Safety (ANSM).
  • Offer expert support for the preparation, submission, and follow-up of promotional materials requiring regulatory validation.

Requirements

About You:

Job Skills

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Quality officer - Orléans

posted by: spj_bot

About the Job

Join Excelya, where Audacity, Care, and Energy define who we are and how we work. As a Senior Expert in Sterility Insurance, you will take on a vital role in ensuring the integrity and safety of our sterilization processes within clinical development.

Your expertise will drive quality assurance in sterilization practices to comply with industry standards and regulatory requirements while fostering a culture of continuous improvement and excellence.

Main Responsibilities:

- Managing task lists and interacting with other peripheral streams (maintenance, logistics, etc.)

- Communicating tasks to the project manager daily and via monthly KPIs.

- Tasks and deliverables for the project and authorities:

• Risk analyses (initiation, execution, conclusion, action plan)

• Drafting quality documents (test protocols/plans and reports, standard operating procedures, operating procedures)

• GAP analysis against GMP

• Scientific justification (documents) for deviations from regulatory requirements

• Monitoring action plans, investigations, and evaluation of out-of-specification (OOS) results

• Drafting the CCS DP

Requirements

About You

Job Skills

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Security Architectures

posted by: spj_bot

Contract duration: Start with 6 months

Location: JHB

Pay rate: Negotiable

Security Architectures

The Head of Security Architecture for the organization is responsible for designing, implementing, and maintaining robust security architectures that protect sensitive data in compliance with regulations such as POPIA, GDPR. This role is critical in safeguarding the confidentiality, integrity, and availability of electronic health records (EHR), patient and employee information, medical devices, and cloud-based healthcare services. The role will focus on designing and developing security architecture that aligns business and corporate security strategy. The role will collaboratively direct Security Architects, IT, and Engineers to design and build security controls and solutions compliant with approved enterprise architecture frameworks and standards across business and digital.

What will you bring?

Risk-based decision-making - expert in ISO 27001 / NIST / CIS controls, able to quantify and articulate risk, then select proportionate, cost-effective controls.

Pen-testing & threat-modelling - scoping, overseeing, and translating results into enforceable patterns and backlog items.

Influential communication - proven ability to engage C-suite and delivery stakeholders alike, adapting style to gain agreement and drive secure-by-design culture.

Job Skills

identity and access management corporate security architecture framework security strategy toolchains cloud platforms on prem GCP communication backlog healthcare service collaboratively governance secure system endpoint protection project managers ldap teamwork best practices antivirus translating control framework firewalls enterprise architecture e c integrate enterprise architecture framework decision make security policy risk based research secure coding cloud architecture collaborates virtual network IAM operational coordination security domain threat modelling advise API electronic records mitigate network segmentation track pen incident response presented managing risk projects cloud security phase validating SAML aligns business security network designing security CISA collaboration security requirements togaf ad vulnerabilities architecture analysis network infrastructure network security private cloud operation validation usability manage security system design design review application architecture security architectures security infrastructure medical device balancing devsecops design thinking computer science security technology security control web application SIEM design leadership coding security pattern security architecture infrastructure encryption scale model threats
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Information Security Architect

posted by: spj_bot

Job title: Information Security Architect

Contract duration: Start with 6 months

First preference: EEE candidates

Location: JHB

The Head of Security Architecture for the organization is responsible for designing, implementing, and maintaining robust security architectures that protect sensitive data in compliance with regulations such as POPIA, GDPR. This role is critical in safeguarding the confidentiality, integrity, and availability of electronic health records (EHR), patient and employee information, medical devices, and cloud-based healthcare services. The role will focus on designing and developing security architecture that aligns business and corporate security strategy. The role will collaboratively direct Security Architects, IT, and Engineers to design and build security controls and solutions compliant with approved enterprise architecture frameworks and standards across business and digital.

Key Responsibilities:

Job Skills

identity and access management corporate security architecture framework security strategy toolchains cloud platforms on prem GCP communication backlog healthcare service collaboratively governance secure system endpoint protection project managers ldap teamwork best practices antivirus information security translating control framework firewalls enterprise architecture e c integrate enterprise architecture framework security policy decision make risk based research secure coding collaborates cloud architecture virtual network IAM operational coordination security domain threat modelling advise API mitigate network segmentation track pen incident response presented ul managing risk projects cloud security phase validating SAML aligns business security network CISA collaboration security requirements togaf ad vulnerabilities architecture analysis network infrastructure network security private cloud health records security design operation validation usability manage security system design design review application architecture security architectures security infrastructure medical device balancing devsecops design thinking computer science security technology security control web application SIEM design leadership coding security pattern security architecture infrastructure encryption scale model threats
View the job post & apply
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