Medical Device Global Marketing Authorizations

Crafting the Future of Healthcare Together

Senior Medical Device Global Regulatory Affairs Consultant

Responsibilities:

• Oversee and guide the global regulatory strategy for medical devices across various markets.

• Engage with health authorities, ensuring that all regulatory submissions meet local requirements.

• Stay updated on global regulatory changes and advise the product teams on compliance strategies.

• Coordinate with cross-functional teams for timely submissions and approvals.

• Lead risk assessment efforts in line with regulatory requirements.

Qualifications:

• Bachelor's or Master's degree in a relevant field.

• Minimum of 8 years of experience in medical device regulatory affairs.

• Proven experience in global markets and deep understanding of regional medical device regulations.

• Strong analytical and communication skills.

Senior Medical Device Clinical Evaluations Consultant
 

Responsibilities:

• Lead the design, planning, and execution of clinical evaluations for medical devices.

• Review and analyze clinical data, ensuring its relevance and validity.

• Collaborate with clinical and regulatory teams to align clinical evaluations with global requirements.

• Guide the preparation of clinical evaluation reports and other documentation.

• Ensure that all clinical evaluations are in compliance with international standards.

Qualifications:

• Advanced degree in a relevant scientific or medical field.

• Minimum of 8 years of experience in clinical evaluations for medical devices.

• In-depth knowledge of clinical evaluation methodologies and international standards.

• Strong critical thinking and report-writing skills.

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Senior Medical Device Quality Assurance Consultant
 

Responsibilities:

• Define and implement quality assurance strategies for medical device production and post-market activities.

• Lead internal audits, ensuring compliance with global standards.

• Guide teams in root cause analysis, CAPA, and continuous improvement initiatives.

• Collaborate with regulatory teams to ensure that QA activities align with regulatory requirements.

• Train and mentor QA teams and other stakeholders.

Qualifications:

• Bachelor's or Master's degree in a related field.

• Minimum of 8 years of experience in quality assurance for medical devices.

• Strong knowledge of ISO 13485, FDA QSR, and other relevant standards.

• Proven leadership and team management skills.

Senior MDSAP Consultant
 

Responsibilities:

• Oversee the implementation and maintenance of the Medical Device Single Audit Program (MDSAP) within the organization.

• Guide teams through MDSAP audits, ensuring readiness and compliance.

• Stay updated on changes within the MDSAP program and adjust strategies accordingly.

• Coordinate with regulatory and QA teams to align MDSAP requirements with internal processes.

• Conduct training sessions on MDSAP requirements and best practices.

Qualifications:

• Bachelor's degree in a relevant field, Master's preferred.

• Minimum of 8 years of experience with MDSAP, including leading audits.

• Deep understanding of MDSAP requirements and processes.

• Strong organizational and training skills.