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Quality And Development Engineer

Actalent

Posted on May 25, 2022 by Actalent

Zuchwil, Solothurn, Switzerland
Sales
Immediate Start
Annual Salary
Contract/Project

Quality And Development Engineer

The Clinical Research Scientist will be responsible for the development of post-market clinical research strategies of orthopedic devices to support global regulatory and post-market surveillance requirements.

Responsibilities include:

Work closely with cross-functional teams (Clinical, Medical, Regulatory, R&D, Marketing) to develop post market clinical evidence generation strategies that consider evidence needs for EU Medical Device Regulations (EU MDR). Facilitate clinical evidence reviews with cross functional team to align on clinical evidence strategies, document/track decisions and risks, and write PMCF Plans.

Develop and write high quality Post-market Clinical Follow-up (PMCF) plans and reports with minimal supervision. Support development and drafting of clinical study protocols, registry plans, epidemiology studies, informed consents, investigator brochures, and other study materials where needed.

Review summaries of clinical evidence and PMCF strategies in other areas of the Technical Documentation for accuracy and completeness. This includes the Clinical Evaluation Plan, Clinical Evaluation Report (CEP), Post Market Surveillance Plan and Periodic Safety Update Report (PSUR).

Maintain strong understanding of evolving post-market evidence requirements under EU Medical Device Regulation.

Where required, foster relationships with surgeons, hospitals and research teams to gain input into study design, evaluate study feasibility, and identify sites for study execution or data collection. Develop strong collaborative relationships with the study core team and others to ensure study progress for assigned projects and that issues are identified and communicated to leaders.

Partner with the Contracts and Payments team to ensure timely execution of all study agreements and corresponding payments for achieved milestones and deliverables.

Support clinical scientific discussions with internal stakeholders within Clinical, Medical, Regulatory, R&D and Marketing to drive support of the clinical and regulatory strategy, communicate evidence needs.

Contribute to appropriate interpretation and dissemination of all evidence generated, including abstracts, manuscripts, and Clinical Study Reports (CSR), epidemiology study results and clinical literature.

Develop a strong understanding of the orthopedic device product portfolio and business needs for clinical evidence to meet regulatory requirements.

Qualifications:

A Bachelor's degree in Biological Science or related discipline, with a minimum of 4 years' experience in the medical device industry or healthcare field is required

Advanced technical writing skills is required, with demonstrated experience in writing PMCF plans/reports strongly preferred.

Strong project management skills required, with demonstrable track record of success managing multiple projects simultaneously with minimal supervision.

Ability to communicate effectively and work with teams is required.

Previous experience developing strategies to generate clinical evidence is strongly preferred.

If interested please apply or reach out directly to (see below)

Job Title: Quality And Development Engineer

Location: Zuchwil, Switzerland

Rate/Salary: 60.00 - 80.00 CHF Hourly

Job Type: Contract

Aerotek and Actalent Services, an Allegis Group company. Allegis Group AG, Basel, Switzerland. Registration No. CHE-101.865.121. Aerotek and Actalent Services are companies within the Allegis Group network of companies (collectively referred to as "Allegis Group"). Aerotek, Actalent Services, Aston Carter, EASi, TEKsystems, Stamford Consultants and The Stamford Group are Allegis Group brands. If you apply, your personal data will be processed as described in the Allegis Group Online Privacy Notice available on our website.

To access our Online Privacy Notice, which explains what information we may collect, use, share, and store about you, and describes your rights and choices about this, please go to the website.

We are part of a global network of companies and as a result, the personal data you provide will be shared within Allegis Group and transferred and processed outside the UK, Switzerland and European Economic Area subject to the protections described in the Allegis Group Online Privacy Notice. We store personal data in the UK, EEA, Switzerland and the USA. If you would like to exercise your privacy rights, please visit the "Contacting Us" section of our Online Privacy Notice for details on how to contact us. To protect your privacy and security, we may take steps to verify your identity, such as a password and user ID if there is an account associated with your request, or identifying information such as your address or date of birth, before proceeding with your request. If you are resident in the UK, EEA or Switzerland, we will process any access request you make in accordance with our commitments under the UK Data Protection Act, EU-U.S. Privacy Shield or the Swiss-U.S. Privacy Shield.

Reference: 1606809330

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