Analytical Expert – Medical Device R&D (m/f/d)

Aequor Consulting; Basel; On-site; CHF 110,000 - 170,000; Full time

Benefits offered by this job

LinkedIn Learning access

5 weeks vacation

Professional certifications support

Reka Card contribution CHF 2400/year

Job summary

Aequor Consulting seeks an Analytical Expert for Medical Device R&D in Basel. You will lead analytical activities for device testing across projects, develop and transfer methods, and coordinate with internal teams and external laboratories to meet regulatory expectations.

You will apply statistical analysis and regulatory knowledge to support registrations and inspections, ensuring high-quality analytical results and robust project outcomes.

Qualifications

• Experience with international ISO standards, Ph. Eur. and USP interpretation and application.
• Analytical method development and transfers to internal/external labs.
• Strong statistical data analysis with practical experience in Minitab.
• Excellent coordination and communication across cross-functional teams.

Responsibilities

• Act as the single point of contact for analytical activities in medical device testing.
• Lead analytical activities across projects and manage external laboratories.
• Develop and transfer project-specific analytical methods to internal/external labs.
• Coordinate with cross-functional device teams and stakeholders at drug product level.
• Contribute to regulatory documentation and project registrations.
• Support regulatory inspections and present analytical work and documentation.

Skills

Analytical thinking

Statistical data analysis

Project coordination

Communication skills

Tools

Minitab

Job description

Analytical Expert – Medical Device R&D (m/f/d)

Are you an experienced analytical specialist with a strong background in medical device testing, analytical method development and statistical data analysis? Do you have in-depth knowledge of international pharmaceutical standards and enjoy coordinating complex analytical activities across multidisciplinary project teams and external laboratories?

For a leading international pharmaceutical company in Basel, an experienced Analytical Expert (m/f/d) is sought to support Research & Development activities within the Medical Device area. In this role, you will take responsibility for analytical activities across assigned projects, contribute to regulatory documentation and ensure the successful development, transfer and execution of analytical testing methods in both internal and external laboratory environments.

Responsibilities

• Act as the single point of contact for all analytical activities related to medical device testing within assigned projects.
• Oversee and lead analytical activities across assigned projects, ensuring alignment with project objectives and customer requirements.
• Develop project-specific analytical methods, including the transfer of methods to internal and external laboratories.
• Select suitable testing laboratories based on resource availability, technical capabilities and the applicable insourcing or outsourcing strategy.
• Lead outsourced analytical project activities at external laboratories and contribute to the management of external partnerships across two independent projects.
• Coordinate analytical activities with cross-functional device project teams and stakeholders at drug product level.
• Contribute to the preparation and review of regulatory documentation and support project registration activities.
• Support regulatory inspections, including the presentation and explanation of analytical activities and relevant documentation.
• Perform and oversee statistical data analysis to ensure reliable analytical results and support project-related decision-making.
  

Requirements

• Extensive expertise in international ISO standards, the European Pharmacopoeia (Ph. Eur.) and the United States Pharmacopeia (USP), including their interpretation and practical application.
• Strong expertise in analytical mechanical testing methods and their practical application within the medical device area.
• Proven experience in analytical method development and method transfers to internal and external laboratories.
• In-depth knowledge of statistical data analysis and strong practical experience with statistical software, particularly Minitab.
• Excellent coordination and communication skills, with the ability to collaborate effectively with cross-functional device project teams and stakeholders at drug product level.
• Experience coordinating external laboratories and managing outsourced analytical activities is highly advantageous.
• Understanding of regulatory documentation and project registration activities within a regulated pharmaceutical or medical device environment.
• High level of motivation, resilience and ability to manage a demanding workload while consistently delivering high-quality results.
• Excellent verbal and written English communication skills.
• Experience with or access to NRV, GLIMS and 1-QEM (Novartis internal systems) is considered an advantage.
• Availability during European working hours to ensure effective coordination of work packages and project status updates.
• 5 weeks of annual vacation based on a 40-hour working week.
• Access to LinkedIn Learning with more than 5,000 online courses.
• Financial support for professional certifications and further education.
• Reka Card contribution of 20%, up to CHF 2,400 per year.