Requirements: English
Company: Pronova Laboratories
Region: Muiden , North Holland
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Join Our Transformative Team: Shape the Future of OTC Medical Devices!
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Pronova is Seeking a Product Development Specialist / Regulatory Affairs Officer
Are you ready to take on a dynamic dual role that combines creativity, analytical rigor, and global impact? We are a small, innovative team revolutionizing the world of over-the-counter (OTC) medical devices that treat various ailments of the skin, throat, nose, and more. From inventing cutting-edge products to navigating complex global regulatory landscapes, we bring ideas to life and ensure they reach markets worldwide.
Were looking for a talented professional with a passion for science, a knack for problem-solving, and a drive to make a difference. This unique role blends product development and regulatory affairs, offering you the autonomy to lead projects, understand market and regulatory needs, and transform them into world-class self-care solutions.
What Youll Love About This Role:
- Impact: Be part of a team thats redefining self-care through innovative medical devices for worldwide users.
- Versatility: Use your scientific expertise to tackle diverse challenges in both product design and regulatory compliance.
- Growth: Shape your own career path, with opportunities to specialize in areas you are passionate about.
- Collaboration: Work closely within a vibrant, multidisciplinary team to deliver products efficiently CE-marked under MDR.
Our Values:
At the heart of our company is a commitment to creating self-care products that truly make a difference. We believe in thinking beyond the ordinary, crafting solutions that set the global standard for quality and reliability.
What Drives Us:
- Pushing Boundaries: We thrive on fresh ideas and bold thinking to develop superior self-care solutions that stand out in a competitive global market.
- Reliability: Whether its the products we design or the relationships we build, trust and dependability are non-negotiable.
- Collaboration: Our close-knit, direct office culture fosters transparency and mutual respect, enabling us to work seamlessly both as a team and with our partners.
- Excellence Through Dedication: We are relentless in our pursuit of excellence, ensuring every product not only meets but exceeds expectationsevery time.
Bring Your Talents:
Were seeking someone with a strong analytical/scientific background, excellent writing skills, and the organizational prowess to manage projects from concept to market launch. If you thrive in a fast-paced environment and love connecting science with real-world applications, we want to meet you!
Core Tasks and Responsibilities:
Developing CE-certified devices, meaning:
- Managing and monitoring development projects
- Defining product requirements and design controls
- Demonstrating compliance to technical design requirements and GSPRs, i.e. designing verification and validation studies; writing protocols; collecting and analyzing data; writing test reports
- Clinical Development, including design and planning of PMCF studies
- Composing and maintaining technical documentation in conformance with Medical Device Regulations and Pronovas QMS procedures
- Co-ordinating the products development with Business Development
- Providing input to the Product Development Manager and the PRRC
Job Requirements:
- MSc degree in pharmaceutical science / pharmacology, medical biology, biotechnology, industrial design, or equivalent
- 2 years experience in a project management position
- 1 year experience in a role concerning MDR compliance
- Trained to work in accordance with a procedural development process
- Hands-on experience with applying Directive 93/42/EEC (MDD), Regulation (EU) 2017/745 (MDR), 21 CFR Part 820, and Risk Management (ISO 14971:2019) to the quality management of medical devices
- Knowledge of Clinical Evaluations (MEDDEV 2.7.1 rev 4) and Clinical Investigations (ISO 14155:2011)
- Pro-active and adaptive attitude
- Goal-oriented and Process-oriented mindset while keeping eye for detail
- Strong verbal and written communication skills in both Dutch and English.
Do you feel like you fit this profile? Then have a look at our product portfolio on