Regulatory Affairs Specialist

05 ott - Modena
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• Role: Regulatory Affairs Specialist (Remote)
• Location: Remote (Work from Anywhere)

Role Overview:
We are hiring for one of our clients, seeking a Regulatory Affairs Specialist to work on a Full-Time basis. The role involves ensuring compliance with evolving regulatory frameworks across multiple jurisdictions while supporting product submissions and approvals. The position requires collaboration with cross-functional teams to align business strategies with regulatory requirements.

Key Responsibilities:
• Prepare, review, and submit regulatory documentation for product approvals in accordance with international and domestic regulatory standards.
• Maintain up-to-date knowledge of changes in global regulatory policies, laws, and guidelines relevant to the industry.
• Liaise with internal stakeholders, regulatory agencies, and external partners to resolve compliance issues and facilitate approvals.
• Conduct regulatory risk assessments and provide strategic guidance to minimize compliance gaps in product development.
• Support post-market surveillance activities,



including adverse event reporting and compliance monitoring.

Required Skills & Qualifications:
• Experience in regulatory submissions for technology or software products, including documentation preparation and agency interactions.
• Knowledge of regulatory frameworks such as GDPR, ISO standards, or sector-specific compliance requirements.
• Strong analytical skills to interpret complex regulations and apply them to business operations.
• Ability to manage multiple deadlines while maintaining accuracy in regulatory filings.
• Excellent written and verbal communication skills to articulate regulatory requirements to non-technical stakeholders.

More About the Opportunity:
This role offers a unique opportunity to work with a global leader in the Technology, Information and Internet industry, contributing to the strategic alignment of regulatory compliance with product innovation. The position requires adap

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