NonStop Consulting
- Location:
- Apeldoorn – Gelderland, Nederland, Netherlands
- Salary:
- Negotiable
- Type:
- Permanent
- Main Industry:
- Search Health, Nursing & Social Services Jobs
- Advertiser:
- NonStop Consulting
- Job ID:
- 131267984
- Posted On:
- 25 October 2024
Job Title: Sr. Regulatory Affairs Specialist
Location: Apeldoorn region, Netherlands
About the Role:
We are seeking a Sr. Regulatory Affairs Specialist with in-depth experience in ISO 13485 and MDR compliance. In this role, you will report directly to the VP, providing high visibility and the chance to make a direct impact on the organization’s regulatory strategies. Based in the Apeldoorn region, this role offers many opportunities for professional growth and development within a dynamic and supportive environment.
Key Responsibilities:
* Lead the creation and implementation of regulatory strategies to ensure compliance with ISO 13485 and MDR standards, aligning tasks across departments to meet regulatory requirements.
* Prepare, compile, and submit regulatory documentation to support product compliance and organizational objectives.
* Act as a regulatory liaison within the organization, collaborating closely with R&D, Quality, and other departments to achieve alignment on compliance tasks and product readiness.
* Stay informed on regulatory changes, particularly in ISO 13485 and MDR, and communicate relevant updates to internal teams.
* Conduct internal audits, support regulatory inspections, and manage any necessary follow-up actions.
* Perform risk assessments and establish preventive actions to ensure ongoing compliance across product lines.
Qualifications:
* Bachelor’s degree in a relevant field (e.g., Life Sciences, Chemistry, Pharmacy).
* Minimum of 4 years of experience in Regulatory Affairs, ideally within the medical device or pharmaceutical industry.
* Strong practical knowledge of ISO 13485 and MDR compliance.
* Fluent in English; proficiency in Dutch or German is a plus.
* Authorization to work in the European Union is required.
* Excellent organizational skills, attention to detail, and the ability to work effectively across departments.
What We Offer:
* Direct reporting to the VP, providing significant influence and exposure within the organization.
* Numerous opportunities for career growth and development in a supportive and innovative environment.
* Competitive salary and comprehensive benefits package.
* Flexible working arrangements to support work-life balance.
If you’re a Regulatory Affairs specialist looking to grow your career in a role with significant impact and development potential, we would love to hear from you!
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