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Manager Regulatory Affairs - Job Opportunity at DORC International

Zuidland, Netherlands
Full-time
Senior
Posted: June 25, 2025
Hybrid
Based on the senior management level, international scope covering 165 countries, and location in the Netherlands with a major medical technology company, the salary range is estimated at €95,000-€125,000 annually. The comprehensive benefits package including 13th month salary, 8% holiday pay, and bonus scheme likely brings total compensation to €120,000-€150,000 annually, which is competitive for senior regulatory affairs roles in the European medical device sector.

Benefits

27 vacation days plus 13 additional days off providing exceptional work-life balance exceeding European standards
8% holiday pay bonus adding significant additional compensation beyond base salary
13th month salary providing substantial year-end financial boost
Performance-based bonus scheme offering additional earning potential tied to achievements
Travel allowance of €0.23 per kilometer covering commuting costs comprehensively
Non-contributory pension plan with full employer funding resulting in higher net take-home pay
Hybrid remote work flexibility enabling optimal work-life integration
Freedom and responsibility culture promoting professional autonomy and innovation
Access to ZEISS global network and resources as part of internationally leading technology enterprise

Key Responsibilities

Lead global Regulatory Affairs strategy across 165 countries, positioning the organization for international market expansion and ensuring competitive advantage through regulatory excellence
Define and execute comprehensive international regulatory approval strategies that directly impact product launch timelines and revenue generation across multiple markets
Oversee global product registrations with full accountability for planning and execution, ensuring seamless market entry and compliance across diverse regulatory environments
Drive continuous process improvement initiatives to reduce time-to-market, optimize resource utilization, and enhance organizational efficiency in regulatory operations
Manage substantial budgets for registrations and personnel while leading recruitment and resource planning to support business growth objectives
Champion cross-functional collaboration and process optimization across R&D, Product Management, Quality, and Clinical Affairs to ensure integrated approach to regulatory strategy
Provide executive-level reporting and serve as primary regulatory contact for internal stakeholders, influencing key business decisions and strategic direction
Lead organizational development initiatives and represent regulatory affairs in product line management, ensuring regulatory considerations are integrated into business strategy

Requirements

Education

Master's degree (or equivalent ability) in related field

Experience

At least 7 years of working experience in related field with minimum of 3 years of managerial experience

Required Skills

Demonstrated ability to manage and align diverse stakeholders across multiple disciplines and organizational levels Strong knowledge of regulatory compliance within the medical technology sector Solid understanding of business processes, digital transformation in medtech, and principles of operational excellence Proven expertise in international product registration for medical devices across Class I, II, and III, in compliance with global regulatory standards Significant leadership experience, including successful team management in a dynamic, cross-functional environment
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Sauge AI Market Intelligence

Industry Trends

The ophthalmic medical device industry is experiencing unprecedented growth driven by aging global populations and increasing prevalence of vision-related disorders, creating significant demand for regulatory professionals who can navigate complex international approval processes. Digital transformation in healthcare is fundamentally changing regulatory frameworks, requiring professionals who understand both traditional compliance requirements and emerging digital health regulations. The medical technology sector is witnessing increased regulatory scrutiny and harmonization efforts across international markets, making expertise in multi-jurisdictional regulatory strategy increasingly valuable. Regulatory affairs professionals in medical devices are facing evolving requirements around cybersecurity, software as medical devices (SaMD), and real-world evidence, necessitating continuous learning and adaptation to new regulatory paradigms. The industry is moving toward more collaborative regulatory approaches with health authorities, requiring professionals who can engage proactively in regulatory science discussions and influence policy development. Post-pandemic regulatory environment has accelerated digital submission processes and virtual interactions with regulatory bodies, creating opportunities for more efficient global regulatory strategies while requiring new technological competencies from regulatory professionals.

Role Significance

Based on the global scope and multi-site operations mentioned, this role likely involves managing a team of 8-15 regulatory affairs professionals across different regions, with additional oversight of local regulatory teams and shared service centers, representing significant people management responsibility.
This is a senior management position with substantial strategic responsibility, evidenced by global scope across 165 countries, budget management authority, team leadership requirements, and direct reporting to business segment head. The role sits at the intersection of business strategy and regulatory compliance, requiring executive-level decision-making capabilities and cross-functional leadership skills.

Key Projects

Global product registration campaigns for new ophthalmic devices across multiple regulatory classifications Implementation of digital regulatory submission systems and process optimization initiatives Cross-functional regulatory strategy development for product lifecycle management Regulatory framework development for emerging technologies in ophthalmology International regulatory harmonization projects and policy influence initiatives

Success Factors

Deep understanding of international medical device regulations combined with strategic business acumen to align regulatory strategy with commercial objectives and market entry plans Exceptional stakeholder management and communication skills to influence diverse internal teams and external regulatory bodies across multiple cultural and regulatory environments Proven ability to build and scale regulatory operations in complex organizational structures while maintaining quality and compliance standards Strategic thinking capability to anticipate regulatory trends and position the organization proactively for future regulatory requirements and market opportunities Change management expertise to drive process improvements and digital transformation initiatives across traditional regulatory functions

Market Demand

High demand driven by expanding global medical device markets, increasing regulatory complexity, and shortage of experienced professionals with international multi-jurisdictional expertise, particularly in specialized sectors like ophthalmology where technical knowledge combines with regulatory acumen.

Important Skills

Critical Skills

International medical device regulatory expertise is absolutely essential as this role requires deep understanding of complex regulatory frameworks across multiple jurisdictions including FDA, EU MDR, Health Canada, and other international bodies. The ability to navigate Class I, II, and III device regulations simultaneously across 165 countries represents a rare and highly valued skill set that directly impacts business success and patient access to ophthalmic treatments. Cross-functional leadership and stakeholder management capabilities are critical because regulatory strategy must be integrated with R&D, clinical affairs, quality, and commercial teams to ensure successful product development and market access. The ability to influence without direct authority and align diverse organizational priorities is essential for driving regulatory excellence in a matrix organization structure. Strategic business acumen combined with regulatory knowledge is vital for this role because regulatory decisions directly impact time-to-market, resource allocation, and competitive positioning. Understanding how regulatory strategy supports business objectives while maintaining compliance integrity is essential for senior-level success in this position.

Beneficial Skills

Digital transformation expertise in regulatory technology and electronic submission systems would provide significant advantage as the industry moves toward more sophisticated regulatory information management and digital interaction with health authorities International business experience and cultural competency would enhance effectiveness in managing regulatory strategies across diverse markets with varying regulatory cultures and business practices Project management and process improvement capabilities would support the continuous improvement mandate and help optimize regulatory operations for efficiency and effectiveness Clinical affairs knowledge would provide valuable context for regulatory decision-making and enhance collaboration with clinical teams on evidence generation and regulatory submissions

Unique Aspects

Opportunity to impact vision restoration globally across 165 countries, providing meaningful work with direct patient outcome benefits in a specialized medical field
Access to ZEISS's world-class technology resources and innovation capabilities while working in a focused ophthalmic specialty environment
Leadership role in a rapidly evolving regulatory landscape for medical devices with significant influence over international market access strategies
Combination of established company stability through ZEISS ownership with entrepreneurial freedom and responsibility characteristic of specialized medical device companies

Career Growth

Typical progression to VP-level roles occurs within 3-5 years given the senior nature of current role and comprehensive international experience being developed, with potential for C-suite regulatory officer positions within 5-8 years depending on business results and leadership development.

Potential Next Roles

Vice President Regulatory Affairs or Chief Regulatory Officer roles with expanded global responsibility and strategic influence over product development and market access strategies General Management positions such as VP Quality & Regulatory Affairs or VP Product Development where regulatory expertise provides foundation for broader operational leadership Consulting leadership roles with top-tier regulatory consulting firms serving multiple medical device companies Senior regulatory leadership positions with larger medical technology companies or emerging digital health organizations

Company Overview

DORC International

DORC International operates as the Dutch Ophthalmic Research Center, specializing in the development and manufacturing of sophisticated ophthalmic surgical equipment, instruments, and solutions used in eye surgery procedures worldwide. As a wholly-owned subsidiary of ZEISS, one of the world's leading technology enterprises, DORC benefits from substantial financial backing, technological resources, and global market presence while maintaining its specialized focus on ophthalmic solutions.

DORC holds a strong position in the specialized ophthalmic surgery market, leveraging ZEISS's reputation for precision optics and medical technology innovation. The company's focus on helping people regain sight positions it in a mission-driven market segment with strong growth potential and significant barriers to entry due to regulatory complexity and technical expertise requirements.
Based in the Netherlands with global operations spanning 165 countries, DORC represents a significant European presence in the ophthalmic device market with strong international reach. The Dutch location provides strategic access to European regulatory pathways while serving as a hub for international market expansion.
The company culture emphasizes hands-on collaboration, innovation, and meaningful impact on patient outcomes, with explicit focus on freedom and responsibility for employees. As part of the ZEISS foundation-owned structure, the organization operates with long-term perspective and commitment to technological advancement rather than short-term profit maximization.
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