Regulatory Affairs Specialist

Important Note (Please Read Before Applying)

Do NOT apply if

• You have less than

  5 years

  or more than

  8 years

  of relevant Regulatory Affairs experience
• You have not worked in the

  medical device

  domain
• You lack hands-on knowledge of

  major regulatory frameworks

  (e.g., US, EU) and

  standards

• You are currently on a

  notice period longer than 30 days

• You are looking for

  remote-only

  roles (this is a

  hybrid position

  , location-based)

Apply ONLY if you meet ALL the mandatory criteria above

Job Title:

Location:

Experience:

Employment Type:

Notice Period:

CTC:

About the Company

Our client is a leading global provider of advanced medical technologies and healthcare solutions, with operations across 50+ countries. They are dedicated to innovation, quality, and regulatory excellence. Their mission is to improve patient outcomes while maintaining the highest standards in product safety and compliance.

• Manage and execute regulatory compliance activities for medical devices across global markets (e.g., US, EU).
• Prepare, submit, and maintain regulatory documentation to support product registrations, renewals, and certifications.
• Review and approve product labeling, packaging, and marketing materials for regulatory compliance.
• Monitor and interpret changes in relevant regulations, standards (e.g., 60601, 14971, 62304), and guidelines.
• Support audits (internal/external), inspections, and regulatory responses under supervision of senior regulatory staff.
• Collaborate with R&D, Quality, and cross-functional teams to ensure regulatory requirements are embedded throughout the product lifecycle.
• Maintain regulatory databases and files with accurate and up-to-date documentation.
• Participate in continuous improvement initiatives related to regulatory processes and documentation quality.

Mandatory Skills

Regulatory Affairs

US CFR

ISO 13485

product registration

technical documentation

audits

Preferred Skills

stakeholder management

project management

cross-functional teams

➕ Proficiency in regulatory databases and document management systems