We are hiring for one of our clients, seeking a Regulatory Affairs Specialist to work on a contract 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 adaptability to changing regulations in a rapid-evolving technological landscape.
Equal Opportunity Employer:
We hire based on skills and expertise. All qualified candidates are welcome regardless of background, experience, or prior employment history. Applications are reviewed solely on demonstrated technical ability and qualifications.