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Regulatory Affairs Officer

posted by: spj_bot

Join Excelya as Regumatory 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 licences, 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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Medical Writer - Clinical Evaluation for Medical Devices

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.

We are currently looking for a Medical Writer focused on Clinical Evaluation for Medical Devices to join our growing team. This position will provide you with the opportunity to work on exciting projects that contribute to the advancement of medical technologies.

Reporting to the Head of Clinical Evaluation & Medical Writing, your primary mission will be to develop and maintain clinical evaluation documentation for implantable medical devices (Class IIb and III).

Main Responsibilities:

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
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Senior Quality Engineer (Remote - US)

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior Quality Engineer in the United States.

We are seeking a seasoned Senior Quality Engineer to support quality assurance efforts in a fast-paced, highly regulated medical device environment. This role will play a key part in ensuring the quality and compliance of software-based products, including those utilizing AI/ML technologies. The ideal candidate will bring deep knowledge of quality standards, risk management, and regulatory compliance, with a proactive approach to continuous improvement and cross-functional collaboration. The position requires experience with software as a medical device (SaMD) and a strong understanding of ISO and FDA regulations.

Accountabilities:

Job Skills

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National Key Account Manager - (Remote - Texas)

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a National Key Account Manager in Texas.

This is an exciting opportunity for a highly driven sales professional to take on a strategic role within the dental services sector. As a National Key Account Manager, you’ll be responsible for managing and growing relationships with large enterprise partners, particularly Dental Service Organizations (DSOs). This role combines leadership, relationship management, and business development. You'll collaborate with both external stakeholders and internal teams to drive platform adoption, performance, and growth. The ideal candidate is a self-starter who thrives in a fast-paced environment and excels at building relationships across all levels of an organization.

Accountabilities:

Job Skills

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Senior Pricing & Contracts Analyst - (Remote - Texas)

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Senior Pricing & Contracts Analyst in Texas.

In this role, you’ll serve as a strategic partner to the commercial team by driving pricing initiatives, supporting contract management, and analyzing profitability across a specialized orthopedic product portfolio. Your contributions will play a key role in optimizing pricing performance, developing competitive proposals, and improving the efficiency of contract processes. You'll collaborate with teams across Sales, Finance, and Product Management to ensure accurate pricing execution and drive data-informed business decisions. This is a high-impact role with room for strategic influence and cross-functional leadership.

Accountabilities:

Job Skills

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Territory Manager - Dresden area, Germany

posted by: spj_bot

About Jobgether

Jobgether is a Talent Matching Platform that partners with companies worldwide to efficiently connect top talent with the right opportunities through AI-driven job matching.

One of our companies is currently looking for a Territory Manager in the Dresden area, Germany.

We are seeking a driven and experienced Territory Manager to oversee sales operations within the assigned region. In this field-based role, you will be responsible for identifying new business opportunities, managing existing customer relationships, and driving revenue growth through the effective promotion and sales of innovative medical device solutions. Working closely with healthcare professionals in clinical environments, you will also provide intraoperative support and patient programming. This is a key position within the sales team, reporting directly to the Area Director - DACH.

Accountabilities:

Job Skills

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