Clinical Development Specialist – Risk Management & Benefit-Risk Analysis

Location: Eindhoven

Start Date: ASAP

Duration of the project: 1 year

Make an Impact on Global Health Innovations

At Philips, we are driven by our mission to improve lives through meaningful innovation. Join us in shaping the future of healthcare by contributing to the development and safety of cutting-edge medical technologies that have the potential to transform billions of lives.

As a Clinical Development Specialist, you will play a pivotal role in clinical development, focusing on risk management and benefit-risk analysis to ensure the safety and efficacy of our products throughout their lifecycles. Your expertise will directly influence the successful development and approval of medical products worldwide.

Key Responsibilities:

Lead benefit-risk analysis and support risk management throughout the product lifecycle.
Collect, appraise, and analyze clinical data for medical devices and solutions.
Develop and write clinical documentation, including Clinical Evaluation Reports (CERs) and Post-Market Clinical Follow-up Reports (PMCFs).
Collaborate with internal teams (project owners, regulatory affairs, statisticians, post-market surveillance, etc.) and external stakeholders (clinical consultants, regulatory agencies) to ensure robust clinical evidence analysis.
Ensure proper dissemination of clinical evidence through comprehensive Clinical Study Reports (CSRs), CERs, and PMCFs.
Support clinical trials and product approvals in key regions including the USA, EU, and ROW.
Lead clinical risk assessments from ideation through to market introduction.
Review and enhance workflows, Standard Operating Procedures (SOPs), and document preparation processes within the Clinical Development department.

Required Skills & Experience:

Master’s degree, Ph.D., or M.D. in Biomedical Sciences or a related health field, with 3-5 years of experience in the medical device or pharmaceutical industry.
In-depth knowledge of benefit-risk analysis and clinical risk management.
Experience with vigilance reporting and/or harm reviews for medical products.
Expertise in medical writing, systematic reviews, and clinical data analysis; experience with MDR-compliant CERs and PMCFs is highly advantageous.
Thorough understanding of GCP, ICH guidelines, ISO 14155, FDA regulations, and EU medical device regulations.
Experience in clinical investigation design, biostatistics, and research methodology.
Proven track record of delivering clinical results on time, within budget, and in compliance with applicable standards and regulations.
Strong collaboration skills and experience working with cross-functional teams and external partners.
Fluency in English (both written and verbal).

What We Offer:

An exciting and dynamic work environment, where you’ll contribute to life-changing healthcare innovations.
Opportunities for personal and professional growth while working on cutting-edge projects.
As part of this role, you will be employed through Randstad and placed within Philips, enjoying the benefits of both organizations.

Arbeidsvoorwaarden

Primary employment conditions

· A good salary as per industry standards(classification depending on education and work experience);

· 13th month salary (is paid out periodically pro rata)

· 8.33% holiday pay calculated over 12 monthly salaries.

Secondary employment conditions

· Pension Plus scheme (build-up from day 1);

· Net €750 to set up your home workplace;

· 25 days of vacation per year based on 40 hours;

· Travel expenses reimbursement;

· Options for working from home with a home work allowance;

· Yacht Academy with a training budget.

· Referral bonuses up to €1,500;

· Fixed HR contact person

· A professional buddy who is always within reach;

· Knowledge & networking events

By joining us, you will engage in projects that have a lasting impact on healthcare and the lives of patients around the world. Take your career to the next level with Philips, and become a part of an inspiring and innovative team!

Interested? Apply with your CV in English and I look forward to talking to you soon!

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