Company Description
Headsbase helps organizations strengthen their workforce through modern, data-informed talent solutions.
The team works closely with clients to understand business goals, optimize hiring processes, and support scalable team growth with the right expertise.
By combining talent advisory, workforce planning, and project-based resourcing, Headsbase focuses on engagements that deliver measurable impact for both short-term initiatives and long-term growth.
Professionals gain access to meaningful opportunities aligned with their skills and career vision, supported by transparent communication and guidance throughout the process.
Headsbase is committed to smarter processes, stronger teams, and sustainable growth for all partners and professionals involved.
Role Description
This remote Regulatory Affairs Specialist role is a contract position focused on supporting clients with their regulatory strategies and obligations.
Day-to-day responsibilities include preparing, reviewing, and maintaining regulatory documentation for products and services, ensuring alignment with relevant regulatory requirements and standards.
The specialist will coordinate and manage regulatory submissions, track their progress, and address questions or feedback from regulatory bodies.
The role also involves monitoring changes in regulatory frameworks, advising stakeholders on compliance implications, and collaborating with cross-functional teams such as quality, legal, and operations.
The Regulatory Affairs Specialist will contribute to process improvements, risk assessments, and best practices to help clients maintain robust regulatory compliance.
Qualifications
- Strong skills in Regulatory Documentation and Regulatory Submissions, including drafting, compiling, and tracking technical and administrative files.
- Experience with Regulatory Compliance and Regulatory Requirements, with the ability to interpret and apply guidance from relevant authorities and standards.
- Background in Regulatory Affairs, preferably supporting products or services in regulated industries (e.g., healthcare, life sciences, medical devices, pharmaceuticals, or similar).
- Ability to analyze complex regulations, identify risks, and provide clear recommendations to internal and external stakeholders.
- Excellent written and verbal communication skills, with attention to detail and strong organizational capabilities.
- Demonstrated ability to work independently in a remote setting, manage multiple deadlines, and collaborate across distributed teams.
- Bachelor’s degree in a scientific, technical, regulatory, or related discipline; advanced degree or relevant certifications (e.g., RAC) are a plus.
- Familiarity with quality management systems, risk management, and documentation control tools is beneficial.