Regulatory Affairs Manager
About the job
- A bachelor's degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related discipline is required.
- At least 7 years of regulatory affairs experience in the healthcare or medical device industry is required, including significant experience coordinating activities across multiple APAC countries.
- Exposure to global regulatory frameworks including European Union Medical Device Regulation, United States Food and Drug Administration regulations, and Medical Device Single Audit Program requirements is mandatory.
- Strong hands-on experience with APAC regulatory submissions and lifecycle management is required.
- Experience with country-specific requirements in major APAC markets, including China, Japan, South Korea, Australia, India, and ASEAN markets, is required.
- Experience managing regulatory submissions for ophthalmic devices or eye-care products, and familiarity with cosmetics and dietary or health supplements in at least one APAC jurisdiction, is required.
- Mandatory experience with a Regulatory Information Management System such as Veeva RIM, Ennov, TrackWise, or MasterControl is required.
- Strong regulatory data management and reporting skills are required.
- Working knowledge of artificial intelligence applications in regulatory affairs and experience with artificial-intelligence-enabled documentation, analytics, or automation tools are required.
- The candidate must be able to integrate digital technologies into regulatory workflows.
- The candidate must be able to independently manage multiple regulatory projects.
- The candidate must demonstrate strong stakeholder engagement across global teams and the ability to translate complex regulatory requirements into clear business actions.
- The candidate must be able to coordinate country-level regulatory activities in a regional hub model through dealers, local agents, and external regulatory consultants.
- The candidate must be able to build standard processes, templates, and key performance indicators for multi-country regulatory execution.
- Experience managing virtual teams or influencing without direct line authority across cultures and time zones is required.
- Execute regulatory strategies for APAC markets in alignment with the global regulatory strategy.
- Define regulatory pathways, including classification, submission routes, and documentation requirements.
- Ensure regional submissions comply with local authority expectations and global standards.
- Incorporate local reimbursement, market access, and competitive intelligence considerations into regulatory planning for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements.
- Support and guide shared-services regulatory affairs teams in preparing, compiling, and submitting regulatory dossiers across APAC markets.
- Support and guide shared-services regulatory affairs teams in managing authority interactions, including deficiency responses, clarifications, and approvals.
- Ensure dossiers are consistent with European Union technical documentation and United States Food and Drug Administration submissions where applicable and with the defined intended purpose of use.
- Lead or oversee electronic submissions through country-specific digital portals and gateways, including NMPA, PMDA, TGA, HSA, CDSCO, and MFDS systems where applicable.
- Assess the regulatory impact of product and process changes against APAC country requirements, European Union Medical Device Regulation change-control expectations, United States Food and Drug Administration design-change regulations, and other applicable regulations and standards.
- Monitor and manage renewals, variations, and post-approval commitments.
- Support global change control and ensure regulatory alignment across regions.
- Coordinate lifecycle and change-management activities across medical devices, lenses, ophthalmic devices, medicinal eye drops, cosmetics, and dietary supplements, ensuring consistent labeling and claims across APAC markets.
- Maintain working knowledge of European Union Medical Device Regulation requirements for technical documentation, post-market surveillance, and vigilance; United States Food and Drug Administration regulations and pathways; and Medical Device Single Audit Program requirements.
- Support global audits and regulatory inspections when required.
- Maintain accurate and complete registration, renewal, submission, and commitment data in Regulatory Information Management Systems or document-management systems.
- Ensure data integrity, traceability, and audit readiness.
- Prepare electronic submissions and track product lifecycles using templates, metadata, tagging, and version control.
- Maintain APAC regulatory affairs dashboards, including submission turnaround time and labeling information.
- Plan and archive electronic submission packages so they can be reused, reformatted, and resubmitted for multiple APAC authorities.
- Manage country-specific registration IDs, license numbers, and expiry dates in the Regulatory Information Management System.
- Use artificial-intelligence tools to improve dossier compilation and structuring, gap assessment, document comparison, regulatory intelligence analysis, and pre-validation of electronic submission packages.
- Ensure compliant use of artificial-intelligence tools with respect to data privacy, validation, and regulatory expectations.
- Improve regulatory affairs operational efficiency through artificial intelligence, automation, and other digital tools.
- Design and continuously improve end-to-end digital submission workflows from authoring through authority upload and archival in collaboration with information technology and global regulatory affairs teams.
- Collaborate with quality assurance, operations, research and development, clinical, supply chain, and marketing or product management teams.
- Provide regulatory guidance during product development and lifecycle changes.
- Support internal, notified-body, United States Food and Drug Administration, and Medical Device Single Audit Program audit readiness.
- Engage with regional commercial, marketing, and market-access teams in APAC to understand product positioning and market needs and translate them into feasible regulatory strategies and labeling or claims approaches.
- Participate in regulatory affairs improvement projects and complete assigned tasks.
- Act as the central point of contact for APAC country regulatory activities, coordinating submissions, renewals, and authority responses with dealers, local agents, and external regulatory consultants.
- Define and maintain standard templates, checklists, and ways of working for country regulatory activities, including registration dossiers, labeling or instructions for use, and variation dossiers.
- Provide functional guidance and virtual leadership to country-level regulatory resources, including onboarding, training on ZEISS standards, and ongoing performance feedback to internal stakeholders.
- Consolidate and maintain an integrated overview of registration status, timelines, and key risks across APAC countries in the Regulatory Information Management System and hub dashboards.
- Identify cross-country synergies and reuse opportunities, including European Union Medical Device Regulation or United States dossiers, harmonized labeling, and common technical files, to accelerate time to market and reduce duplication.
- Prior regulatory experience covering at least two APAC categories, including ophthalmic medical devices, drug-device combination products, cosmetics, and dietary or health supplements, is strongly preferred.
About the company
ZEISS is a global leader in optics and optoelectronics, serving medical professionals, industrial manufacturers, consumers, and the semiconductor industry. It designs and sells high-precision optical instruments, medical devices, semiconductor manufacturing equipment, and vision care products such as corrective lenses and eye-health services. Its products rely on advanced optics and imaging technologies to deliver accurate inspection, diagnosis, and manufacturing outcomes across healthcare, industrial quality control, consumer optics, and chip fabrication. What sets ZEISS apart is its breadth and depth: a long-standing scale in multiple markets, integrated solutions across optics, imaging, metrology, and precision engineering, and a commitment to sustainability in electricity use and carbon emissions. The company’s goal is to advance optics and optoelectronics by providing reliable, high-quality tools and services worldwide while operating in a sustainable way.
Company Size
1,001-5,000
Company Stage
Growth Equity (Non-Venture Capital)
Total Funding
$1.1B
Headquarters
Oberkochen, Germany
Founded
2001
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Simplify's Take
What believers are saying
- First-half 2025/26 revenue reached €5.841 billion, with EBIT rising to €955 million.
- ZEISS CLINIC 360 won FDA 510(k) clearance on August 19, 2026.
- EURETINA 2026 launches expanded retina imaging, cataract systems, and DORC brand integration.
What critics are saying
- ZEISS Meditec plans up to 1,000 cuts by 2029, signaling margin pressure.
- Göttingen workers entered mediation in February 2026 after Zeiss targeted roughly 140 jobs.
- ASML scanner timing controls ZEISS SMT revenue; any slip delays optics demand immediately.
What makes Zeiss unique
- ZEISS supplies ASML's exclusive EUV optics, anchoring High-NA lithography through 2030.
- ZEISS Medical Technology bundles imaging, software, and surgery across one ophthalmic workflow stack.
- ZEISS CLINIC 360 and Collaborative Care tie devices, cloud analytics, and referrals together.
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Benefits
Health Insurance
401(k) Retirement Plan
Paid Vacation
Performance Bonus
Growth & Insights and Company News
6 month growth
4%1 year growth
4%2 year growth
4%ZEISS Semiconductor Manufacturing Technology (SMT) has launched two systems for advanced chip packaging: ZEISS NLX and ZEISS DUNE. The company announced them in San Francisco on October 12, 2026, as chips grow more complex. ZEISS NLX inspects the inside of chip packages without damaging them. It helps manufacturers spot defects in connections between stacked dies early, and it handles 300-millimetre wafers in both process development and high-volume production. ZEISS DUNE measures the topography of a wafer and corrects wafer bow individually. This helps avoid yield losses in downstream processing and prepares bonding processes. ZEISS SMT is showing the systems at SEMICON West, alongside its photomask tools. The company is also marking 100 years of business in the US in 2026.
ZEISS Medical Technology has announced expansions to its ZEISS Retina Workflow at the EURETINA 2026 congress in Vienna. The company introduced the ZEISS ALTA DUO 300, combining OCT and fundus imaging in a single device for streamlined retinal diagnostics. ZEISS also unveiled the HMDmd CR3, a head-mounted 3D display that connects with the ZEISS ARTEVO 850 surgical microscope. The company reported that its DORC ILM-BLUE and DORC MEMBRANEBLUE-DUAL vitreoretinal surgical dyes reached a 3 million milestone. Additionally, ZEISS announced that the DORC brand will be consolidated under the ZEISS brand name, unifying the company's ophthalmic offerings. The DORC TDC VELOCE cutter continues to show improvements in 27G vitrectomy procedures, with clinical data suggesting up to 41% shorter core vitrectomy times.
ZEISS Medical Technology has expanded its retinal imaging portfolio with the launch of ZEISS ALTA DUO 300, a fully automated, compact multimodal imaging solution. The device combines optical coherence tomography (OCT) and fundus photography in a single unit, designed to provide efficient retinal assessment for eye care practices. The ALTA DUO 300 features four key diagnostic technologies: automated structural OCT with reference database and reporting, true colour fundus camera, AI-enhanced OCT-Angiography, and full chamber depth anterior OCT scanning. The device aims to integrate retinal imaging into everyday patient care through simplified workflows. The product will be showcased at the European Society of Retina Specialists congress in Vienna from 1-4 October and will be available in select markets later in 2026.
ZEISS Medical Technology has launched a cataract-only configuration of its DORC EVA NEXUS ophthalmic surgical system. The system features a cataract grade selection with up to four programmable presets, allowing surgeons to optimise phaco, aspiration, and irrigation settings for each surgical step. The solution includes VacuFlow VTi pump, SMART IOP, and EVA EQUIPHACO technologies, designed to provide streamlined performance, stability, and control during procedures. It integrates with the ZEISS Cataract Workflow portfolio. The system debuted at the European Society of Cataract and Refractive Surgeons congress in London. It will become available in select European countries from September 2026, with global rollout pending regulatory approvals. The technology expands ZEISS's existing EVA NEXUS platform, which previously focused on retina workflows.
ZEISS Medical Technology announced FDA 510(k) clearance for ZEISS CLINIC 360, a cloud-based software solution that aggregates ophthalmic clinical data and provides advanced analytics. The browser-based platform combines diagnostic and medical data into a comprehensive patient view, helping clinicians evaluate disease progression and support treatment decisions. The solution integrates data from DICOM-enabled diagnostic devices, including ZEISS's CIRRUS, CLARUS and HFA systems, as well as third-party devices. It features disease-based summaries, interactive analysis tools, and collaboration capabilities through ZEISS Collaborative Care. ZEISS CLINIC 360 will be available in the US in early autumn 2026 on a subscription basis with low upfront costs. The platform complements ZEISS FORUM, the company's on-premise data management system, giving providers flexibility in choosing their preferred infrastructure approach.