Remote - Regulatory Affairs Specialist - Transfer Project - Med Device

Talascend is seeking a Fully Remote Regulatory Affairs Specialist for a Site Transfer Project to support the relocation of site licenses for medical devices between two manufacturing locations. This role involves assessing country-specific regulatory requirements, collaborating with the central project team, and executing global product registrations. The position supports services that are directly or indirectly invoiced to the client through various contractual arrangements (e.g., time and materials, statements of work, purchase agreements, or direct labor).

This is a 1-year contract role with benefits.

Roles and Responsibilities:

• Provide regulatory input to ensure product compliance in target markets.
• Develop regulatory strategies and submission pathways considering country-specific requirements, product claims, and submission sequencing.
• Collaborate with cross-functional teams to prepare and submit regulatory documents such as MDR EU Technical Files or submissions to global regulatory bodies (e.g., NMPA, TGA).
• Assess product changes to determine the need for new or revised licenses or registrations.
• Develop and manage plans for timely renewal submissions to ensure uninterrupted product supply.
• Review and approve advertising and promotional materials for regulatory compliance and approved claims.
• Contribute to the writing and editing of technical documentation.
• Research and compile background information for regulatory submissions from diverse sources.
• Ensure adherence to pre- and post-market approval requirements.
• Support regulatory inspections and audits as needed.

Required Qualifications:

• Bachelor's degree in Science, Engineering, Regulatory, Legal, or a Life Science-related field from an accredited institution.
• Minimum of 2 years of experience in a regulated industry, preferably in Regulatory Affairs, or in related areas such as Quality Assurance, Design, or Engineering.
• Proficiency in English with strong verbal and written communication skills.
• Experience using Microsoft Office applications (Word, Excel, PowerPoint, Teams, etc.).

Preferred Qualifications:

• Regulatory Affairs Certification (RAC) from the Regulatory Affairs Professionals Society (RAPS).
• Experience in medical device regulatory affairs.
• Strong problem-solving and project management abilities.

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