Product Development Specialist
Job Title: Regulatory Product Manager
Are you ready to take on a dynamic dual role that combines creativity, analytical rigor, and global impact? This is an exciting opportunity to join an innovative team focused on developing over-the-counter (OTC) medical devices that address a variety of health concerns, including skin, throat, and nasal conditions.From inventing cutting-edge products to navigating complex regulatory landscapes, this role plays a crucial part in bringing impactful solutions to global markets.
We are seeking a talented professional with a passion for science, problem-solving skills, and a drive to make a difference. This unique role blends product development and regulatory affairs, offering the autonomy to lead projects, understand market and regulatory requirements, and transform them into high-quality self-care solutions.
Key Responsibilities:
- Manage and monitor product development projects
- Define product requirements and design controls
- Design and execute verification and validation studies, including protocols, data analysis, and test reports
- Plan and oversee PMCF studies
- Prepare and maintain technical documentation in compliance with MDR and quality management systems
- Collaborate with business development teams to align product strategies
- Provide input to senior management on project progress and regulatory considerations
Key Requirements:
- MSc degree in pharmaceutical science, pharmacology, medical biology, biotechnology, industrial design, or related field
- Minimum of 2 years of experience in project management
- At least 1 year of experience in MDR compliance
- Experience with Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (MDR), 21 CFR Part 820, and ISO 14971:2019
- Knowledge of Clinical Evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011)
- Strong organizational skills with attention to detail
- Proactive and adaptable mindset
- Excellent written and verbal communication skills in both Dutch and English
This role offers the opportunity to work in a collaborative environment where innovative thinking, reliability, and dedication to excellence are valued. If you're passionate about connecting science with real-world applications and contributing to impactful healthcare solutions, we'd love to hear from you.
Interested candidates are encouraged to apply and share their vision for this role.
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