Regulatory Affairs Manager
2 weeks ago
elliquence has a 50-year heritage of technological distinction and global presence in the fields of neurosurgery, endoscopic spine, orthopedic and pain management. Our vision has been to partner with the medical community and develop innovative, high quality, cost-effective products benefiting patients, physicians, and medical facilities.
The responsibilities of the Regulatory Affairs Manager are to prepare global regulatory submissions and communicate regulatory strategies to product development teams, and to be responsible for development, maintenance, and review of submissions, documentation, labeling, and procedures while helping to lead and expand the RA team as the regulatory department continues to grow.
Principal Responsibilities
• Prepare and provide guidance for other employees related to the required documentation and testing for global regulatory submissions and registrations.
• Review and approve labeling and promotional materials to ensure compliance with FDA and international requirements.
• Review and approve all design control documentation, engineering change requests for design, manufacturing, and labeling changes and custom’s requests to ensure compliance with FDA and international government regulations.
• Work with consultants to manage all submissions for a particular country or countries.
• Maintain the company's medical device listing and device establishment registrations.
• Handle FDA customs import/export requests, customer service needs, and other requests from internal customers.
• Represent the company with regards to regulatory strategies, submissions, and discussions/negotiations with regulatory authorities
• Write and revise department standard operating procedures (SOP’s)
• Responsible for ensuring that company submissions are filed in accordance with all appropriate regulations (FDA, ISO, CE, EU, CFDA, etc.)
• Responsible for ensuring all data and information supplied is both truthful and accurate
Education & Skills Requirements
• Bachelor's degree or higher. Engineering, life sciences, regulatory affairs degree preferred.
• Medical device regulatory affairs experience required, with thorough understanding of FDA and international medical device regulations.
• RAC certification desired.
• Experience in Technical Files/Documentation, CE Certifications, and Notified Body submissions.
• Proven leadership skills desired.
• Ability to work with minimal to no guidance from management to perform job function.
• Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology, technical product information, and complex documents.
• Ability to write detailed technical regulatory submissions, reports, and business correspondence.
• Ability to respond to inquiries and complaints from customers and regulatory agencies.
• Ability to effectively present information to other employees, management, and regulatory agencies
• Ability to assess, prioritize, and complete multiple projects, tasks, and/or responsibilities.
• Strong computer skills, including Microsoft Office Suite and Microsoft Outlook.
• Ability to work well in a cross-functional setting.
As a global company, elliquence educates physicians on the least invasive procedural solutions for spine pathology and provides our unique and specialized tools to support these procedures. The procedures are truly the least invasive solutions available today, and generally begin with targeting the spinal anatomy with a spine needle. Our tag line, “Less is More” is the absolute truth.
What we offer:
Base salary and annual performance-based bonus.
Medical, dental, vision and life insurance
401(k)
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