Regulatory Affairs Manager (Medical Device)

Purpose of this position / Position summary:

The Regulatory Affairs Manager– APAC is an individual contributor responsible for independently managing regulatory submissions, ap-provals, and lifecycle compliance across APAC markets. The role also requires strong global regulatory awareness, including EU MDR, US FDA, and MDSAP frameworks, ensuring alignment of regional activities with global compliance expectations. The role covers a broad portfolio of medical devices (including but not limited to ophthalmic devices, intraocular lenses, contact lenses, surgical accessories), drug products such as ophthalmic eye drops, as well as cosmetics and dietary supplements where applicable in the Asia Pacific region. The Regulatory Affairs Lead – APAC is responsible for ensuring that market access strategies, submissions, and lifecycle activities reflect coun-try specific market needs, regulatory expectations, and competitive dynamics in key APAC markets (e.g. China, Japan, South Korea, Aus-tralia, New Zealand, India, ASEAN countries).

Primary duties and responsibilities

• Regulatory Strategy & Execution (APAC with Global Alignment):
• Execute regulatory strategies for APAC markets aligned with global regulatory strategy
• Define regulatory pathways including classification, submission routes, and documentation requirements.
• Ensure regional submissions comply with both local authoritys expectations and global standards.
• Tailor regulatory strategies to APAC market needs by incorporating local reimbursement, market access, and com-petitive intelligence considerations into regulatory planning for ophthalmic devices, lenses, eye drops, cosmetics, and dietary supplements.

End-to-End Submission Ownership

• Support and guide SSC RA teams to prepare, compile, and submit regulatory dossiers across APAC markets.
• Support and guide SSC RA teams to manage authority interactions including deficiency responses, clarifications, and approvals.
• Ensure consistency of dossiers with EU Technical Documentation / US FDA submissions where applicable and de-fined intended purpose of use.
• Lead or oversee (electronic) submissions via country specific digital portals and gateways (e.g. NMPA, PMDA, TGA, HSA, CDSCO, MFDS systems as applicable), ensuring correct use of local e submission formats, templates, and structured data requirements.

Lifecycle & Change Management

• Assess regulatory impact of product and process changes considering:
• APAC country requirements
• EU MDR change control expectations
• US FDA 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 multiple product categories (medical devices includ-ing lenses and ophthalmic devices, medicinal eye drops where applicable, cosmetics, and dietary supplements) en-suring coherent change strategies and consistent labeling and claims across APAC markets.

Global Regulatory Compliance Awareness

• Maintain working knowledge of:
• EU MDR (2017/745) requirements for technical documentation, PMS, and vigilance
• US FDA regulations (21 CFR, 510(k), De Novo, PMA pathways)
• MDSAP requirements and audit structure
• Ensure APAC regulatory strategies are aligned with global submissions and compliance frameworks.
• Maintain awareness of how EU and US regulatory expectations for ophthalmic devices, intraocular lenses, contact lenses, eye drops, cosmetics and dietary supplements influence APAC requirements (e.g. reliance pathways, recog-nition of FDA/MDR approvals, MDSAP based inspections).
• Support global audits and regulatory inspections when required.

RIMS (Regulatory Information Management System)

• Maintain accurate and complete data in RIMS or Doc management systems (registrations, renewals, submissions, commitments).
• Ensure data integrity, traceability, and audit readiness.
• Hands on experience with (electronic) submission preparation and lifecycle tracking, including use of templates, metadata, tagging, and version control to support efficient initial submissions, responses to authority queries, and resubmissions.
• Maintain APAC RA dashboards and regularly keep them updated, Example: Turn around time for submission, La-beling, etc
• Ensure that (electronic) submission packages (dossiers, data sets, labeling) are planned and archived in a way that supports reuse, reformatting, and resubmission for multiple APAC authorities, including management of coun-try specific registration IDs, license numbers, and expiry dates in RIMS.

AI-Driven Regulatory Excellence:

• Leverage AI tools to improve efficiency in:
• Dossier compilation and structuring
• Gap assessment and document comparison
• Regulatory intelligence analysis
• Pre validation of electronic submission packages (e.g. structure, metadata, completeness checks) prior to upload into authority portals, using AI or rules based tools where appropriate.
• Ensure compliant use of AI tools with respect to data privacy, validation, and regulatory expectations.
• Bring more operational efficiency in RA domain by leveraging AI, Automation and other digital tools
• Ability to design and continuously improve end to end (digital) submission workflows (from authoring to authority upload and archival) in collaboration (with IT) and global RA, ensuring data integrity and inspection readiness.

Cross-functional Collaboration:

• Collaborate with QA, Operations, R&D, Clinical, Supply Chain, and Marketing/Product management teams.
• Provide regulatory guidance during product development and lifecycle changes.
• Support audit readiness (internal, notified body, FDA, MDSAP audits).
• Engage with regional commercial, marketing, and market access teams in APAC to understand product position-ing and market needs, and to translate these into feasible regulatory strategies and labeling/claims approaches for ophthalmic products, cosmetics, and dietary supplements.
• Participate in RA improvement projects and complete the tasks as assigned.

APAC Country RA Hub Responsibilities:

• Act as the central point of contact for all APAC country regulatory activities, coordinating submissions, renewals, and responses to au-thority questions with dealers, local agents, and external RA consultants.
• Define and maintain standard templates, checklists, and ways of working for country RA activities (registration dossiers, labeling/IFU, variation dossiers) to ensure consistency and efficiency across markets.
• Provide functional guidance and virtual leadership to country level RA resources (dealers, distributors, consultants), 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 all APAC countries in RIMS and hub dashboards, enabling proactive planning and escalations.
• Identify synergies and re use opportunities between countries (e.g. leveraging EU MDR/US dossiers, harmonized labeling, common technical files) to accelerate time to market and reduce duplication.

Education requirements / Experience / Job Specifications:

• Bachelors degree in Life Sciences, Biomedical Engineering, Pharmacy, or related discipline
• Prior regulatory experience covering at least two of the following categories in APAC is strongly preferred: ophthalmic medical devices (including lenses), drug device combination products (e.g. medicated eye drops), cosmetics, and dietary supple-ments/health supplements.
• Strong experience with APAC regulatory submissions and lifecycle management.
• Exposure to global regulatory frameworks (EU MDR, US FDA, MDSAP) is mandatory.

Experience:

• Work Experience: 7+ years in regulatory affairs within the healthcare / medical device industry, including significant experience coordinating regulatory activities across multiple APAC countries (hub role) and working with dealers, in country RA agents, or external con-sultans.

Knowledge / Skills / Other characteristics.

• Regulatory Expertise
• Strong hands-on experience with APAC submissions.
• Proven experience with country specific requirements in major APAC markets (e.g. China, Japan, South Korea, Aus-tralia, India, ASEAN), including dossier formats, local testing/translation expectations, and typical authority ques-tions for ophthalmic products.

Working knowledge of:

• EU MDR technical documentation and PMS requirements
• US FDA submission types and regulatory pathways
• MDSAP audit principles and compliance expectations
• Managing regulatory submissions for ophthalmic devices and/or eye care products (e.g. lenses, eye drops) and familiarity with requirements for cosmetics and dietary/health supplements in at least one APAC jurisdiction.
• Ability to independently manage multiple regulatory projects.

RIMS & Digital Systems

• Mandatory experience with RIMS (Veeva RIM, Ennov, TrackWise, MasterControl, etc.).
• Strong regulatory data management and reporting skills.

AI & Digital Competency

• Working knowledge of AI applications in regulatory affairs.
• Experience with AI-enabled tools for documentation, analytics, or automation.
• Ability to integrate digital technologies into regulatory workflows.

Communication & Collaboration

• Strong stakeholder engagement skills across global teams.
• Ability to translate complex regulatory requirements into clear business actions.