Product Development Manager

Il y a 5 mois

Bruxelles Jette, Belgique Lavima Fertility Temps plein

Responsibilities:
1) Lead and Execute Product Development:

- Lead and execute the final stages of product development for our hormone-free IVF treatment.
- Collaborate with different stakeholders (internal and external) to ensure the product meets quality and regulatory standards.

2) Quality Standards:

- Ensure adherence to quality standards throughout the product development life cycle.
- Collaborate with external quality organization to establish and maintain high-quality benchmarks.
- Implement ISO 13485 standards and 21 CFR Part 820 for medical device product development.

3) Regulatory Compliance:

- Write and review technical documentation for regulatory submissions in various territories worldwide.
- Stay up to date of regulatory requirements and ensure compliance in all target markets.

Qualifications:

- Strong product and project management skills with a track record of successful product launches in the field of medical devices in medical indications.
- Proven experience in medical device product (class II and/or combination product) development (>5-10 years).
- Familiarity with primarily EU and US regulatory requirements, ISO13485 and 21 CFR part 820.
- Master's or advanced degree in a relevant scientific, medical or engineering field.
- Excellent written and verbal communication skills.
- Ability to work collaboratively in a dynamic and fast-paced environment.

Personal Attributes:

- Ambitious and driven individual with a passion for making a positive impact in Women's health.
- Adaptable and able to thrive in a startup culture and in a small team which lives in different countries.
- Demonstrated ability to take initiative and lead and execute projects independently.

How to Apply:
**Experience**:

- medical device product development: 5 years (required)

Work Location: Hybrid remote in 1090 Brussel

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