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:

1. Manage and monitor product development projects
2. Define product requirements and design controls
3. Design and execute verification and validation studies, including protocols, data analysis, and test reports
4. Plan and oversee PMCF studies
5. Prepare and maintain technical documentation in compliance with MDR and quality management systems
6. Collaborate with business development teams to align product strategies
7. Provide input to senior management on project progress and regulatory considerations

Key Requirements:

1. MSc degree in pharmaceutical science, pharmacology, medical biology, biotechnology, industrial design, or related field
2. Minimum of 2 years of experience in project management
3. At least 1 year of experience in MDR compliance
4. Experience with Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (MDR), 21 CFR Part 820, and ISO 14971:2019
5. Knowledge of Clinical Evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011)
6. Strong organizational skills with attention to detail
7. Proactive and adaptable mindset
8. 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.