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Regulatory Affairs Officer - Product Owner - Job Opportunity at DORC International

Netherlands
Full-time
Senior
Posted: April 29, 2025
On-site
€75,000 - €95,000 annually based on Dutch market rates for senior regulatory affairs positions in medical devices

Benefits

Generous leave policy with 27 vacation days and 13 ADV days for 40-hour work week, significantly above market average
Comprehensive compensation package including 8% holiday pay and 13th month bonus, demonstrating strong total rewards approach
Performance-based bonus scheme aligning individual success with company goals
Competitive travel allowance of €0.23/km supporting work-life balance
Non-contributory pension plan offering superior net salary advantage
Modern work tools including company laptop and smartphone
Premium onsite dining facility with fresh food options

Key Responsibilities

Lead global regulatory strategy development for new medical device products, ensuring multi-market compliance
Maintain strategic oversight of international regulatory standards and drive organizational compliance awareness
Serve as core regulatory expert for R&D projects, providing critical guidance on compliance requirements
Direct impact assessment and documentation processes for product/process changes across global markets
Provide strategic regulatory consultation to New Product Development and Sustaining teams
Drive continuous improvement initiatives in regulatory processes and compliance frameworks

Requirements

Education

Minimum of a bachelor's degree in a relevant technical direction or in Life Science

Experience

Minimum of 5 years in the medical device industry in a regulatory position

Required Skills

Thorough knowledge of technical product and process standards and key regulatory frameworks Ability to effectively translate and communicate regulatory requirements into technical language Ability to critically and constructively review technical documentation for compliance with standards Ability to multi-task and methodically manage projects Strong self-motivation and independent work capabilities Excellent communication/interpersonal skills Fluent in English (written and spoken) Advanced level in Microsoft Office
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Sauge AI Market Intelligence

Industry Trends

Growing complexity in medical device regulations with increasing focus on software and cybersecurity compliance Shift towards harmonized international standards requiring expertise in multiple regulatory frameworks Rising importance of post-market surveillance and real-world evidence in regulatory strategy

Role Significance

Likely part of a 5-10 person regulatory affairs team within larger R&D organization
Senior strategic position with direct impact on product development and market access

Key Projects

New product development regulatory strategy and compliance planning Global technical file maintenance and updates Regulatory process improvement initiatives

Success Factors

Deep understanding of international medical device regulations and standards Strong stakeholder management abilities across R&D, quality, and business functions Strategic thinking balanced with practical implementation capabilities

Market Demand

High demand with growing regulatory complexity in medical device industry and ZEISS's market expansion

Important Skills

Critical Skills

Regulatory strategy development for medical devices Technical documentation review and compliance assessment Stakeholder communication and project management

Beneficial Skills

Experience with ophthalmology devices Understanding of software validation requirements Knowledge of quality management systems

Unique Aspects

Role combines traditional regulatory affairs with product ownership responsibilities
Position within ZEISS organization offers broader career opportunities
Focus on ophthalmic devices provides specialized expertise development

Career Growth

2-4 years in role before advancement opportunity, depending on performance and company growth

Potential Next Roles

Global Regulatory Affairs Manager Head of Regulatory Affairs Quality and Regulatory Director

Company Overview

DORC International

DORC (Dutch Ophthalmic Research Center) is a specialized medical device manufacturer now part of ZEISS, focusing on ophthalmic surgery equipment

Strong position in ophthalmic surgical devices market with ZEISS backing enhancing growth potential
European headquarters with global market reach through ZEISS network
Innovation-focused environment with emphasis on quality and technical excellence
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