Sr. Regulatory Affairs Specialist

Job Description

• Generate, confirm, and prepare technical documentation for international submissions and tenders, ensuring compliance with regulatory guidelines and internal standards.
• Research, collect data, and address requests from regulatory agencies to prepare documentation required for health authority submissions.
• Coordinate, compile, and supply regulatory documents to global teams (Latin America, Asia Pacific, Europe, Middle East, and Africa) for new product registrations, introductions, renewals, and change submissions.
• Work with regulatory partners to ensure rapid and timely approval of regulatory submissions.
• Participate on project teams for publishing regulatory documents and labeling creation as needed.
• Edit, format, and finalize high-quality submissions and labeling using company publishing tools, technology, and systems.
• Perform operational tasks such as publishing, archiving, uploading documents to document management systems, and maintaining components of regulatory submissions and labeling (including template preparation, scanning, printing, and filing).
• Collect, import, and create documents in electronic documentation storage and retrieval systems; establish and organize electronic structures for local storage, including migration and maintenance of regulatory documents.
• Collaborate with Regulatory Affairs staff to prioritize and dispatch routine regulatory submissions and labeling creation.
• Collaborate with Global and Regional RA teams on process improvement initiatives (e.g. to expedite submissions, etc.)
• Maintain document design consistency across all documents, ensuring compliance with company standards and templates.
• Assist in preparing training materials and conducting training for users of electronic documentation systems and authors of regulatory documents.
• Provide authentication of documentation and support as a notary when needed.
• Coordinates legalization and/or apostille of regulatory documentation for Health Authority submissions as needed.
• Routes documentation in the Quality Management Systems (e.g. QUMAS, Agile, etc.) as needed.
• Conducts impact assessments for regulatory external requirements (e.g. standards, guidance documents, regulations, etc.)
• Compiles, manages, tracks and reports submission related metrics.
• Drive process consistency and standards within assigned region and collaborate with team members to ensure global alignment.
• Monitor external regulatory environment to ensure compliance with new regulations and requirements.
• Apply general regulatory concepts, practices, and techniques to develop solutions for moderately complex problems.
• Work independently with minimal supervision, leveraging prior regulatory experience.

We are a company committed to creating diverse and inclusive environments where people can bring their full, authentic selves to work every day. We are an equal opportunity/affirmative action employer that believes everyone matters. Qualified candidates will receive consideration for employment regardless of their race, color, ethnicity, religion, sex (including pregnancy), sexual orientation, gender identity and expression, marital status, national origin, ancestry, genetic factors, age, disability, protected veteran status, military or uniformed service member status, or any other status or characteristic protected by applicable laws, regulations, and ordinances.

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• 5+ years of experience in regulatory affairs
• Strong experience with international registration
• Strong experience researching, collecting, and addressing requests from regulatory agencies
• Experience in the Medical Device Industry
• Bachelor's Degree

Benefit packages for this role will start on the 1st day of employment and include medical, dental, and vision insurance, as well as HSA, FSA, and DCFSA account options, and 401k retirement account access with employer matching. Employees in this role are also entitled to paid sick leave and/or other paid time off as provided by applicable law.