International Regulatory Specialist

REVUP CONSULTING PTE. LTD.; Dublin; On-site; EUR 75,000 - 100,000; Full time

Job summary

REVUP CONSULTING PTE. LTD. in Ireland is seeking a Regulatory Affairs professional to plan and run medical device registrations across US, EU and APAC markets. You will coordinate with internal teams, distributors and local partners under the Regulatory Manager's guidance.

You will manage dossiers, respond to authorities and maintain technical documentation for risk management, V&V, labeling and software evidence. A strong knowledge of ISO standards is essential.

Qualifications

• 3–6 years of Regulatory Affairs experience in medical devices.
• Experience with FDA 510(k) and EU MDR.
• Knowledge of ISO 13485 and ISO 14971.
• Ability to manage multiple registrations and deadlines at once.

Responsibilities

• Plan, prepare, submit and track registrations across US, EU, APAC.
• Respond to authority queries and manage approvals, renewals and licenses.
• Assess regulatory pathways for new markets.
• Maintain technical documentation (risk management, V&V, software, labeling).
• Act as regulatory contact for distributors and local reps.
• Support QA on post-market surveillance and audits.
• Monitor regulatory changes, especially for software, robotics and AI devices.

Skills

Regulatory strategy

Documentation

Project management

Education

Bachelor's degree in Biomedical Engineering, Life Sciences, Pharmacy, Engineering or related field

Job description

The Role

You will plan and run medical device registrations across multiple international markets, working closely with internal teams, distributors and in-country regulatory partners. This role reports to the Regulatory Manager.

What You'll Do

• Prepare, submit and track registration dossiers across priority markets (US, EU, APAC)
• Respond to authority queries and manage approvals, renewals and licence validity
• Assess regulatory pathways and classification for new markets
• Build and maintain technical documentation (risk management, V&V, software, clinical evidence, labelling, IFU)
• Assess regulatory impact of product, software, labelling and supplier changes
• Act as the main regulatory contact for distributors and local representatives
• Support QA on post-market surveillance, adverse event reporting, audits and inspections
• Track regulatory changes, especially for software, robotics and AI-enabled devices

What You'll Need

• Degree in Biomedical Engineering, Life Sciences, Pharmacy, Engineering or related field
• 3 to 6 years of Regulatory Affairs experience in medical devices
• Hands-on experience with FDA 510(k), EU MDR and international market registrations
• Working knowledge of ISO 13485 and ISO 14971
• Able to manage multiple registrations and deadlines at once
• Strong documentation