San Diego, CA, USA
2 months ago
Our client is a global in the mobile and wireless medical technology industry.
Prepare, submit, track regulatory documents and submissions to make sure submissions are finished, timely, and regulatory objectives are met. Research scientific and regulatory information in order to write, edit, and review reports. Work with various governmental and regulatory bodies to ensure compliance and quicken approval of pending registration. Compile all material required for submissions, license renewals, and annual registrations. Identify relevant guidance documents and interpret international/consensus standards. Participate in internal or external audits and inspections.
· Support/organize/write regulatory submission for new products (including software as medical devices (SaMD) and product changes as required ensuring timely approval for market release and in accordance with applicable regulations, standards and guidance.
· Maintain current knowledge of the development and changes to applicable laws, regulations and industry standards, and assist in the dissemination of this information to the appropriate individuals within the company and sector.
· Generate/support the creation of technical files, essential requirements and declaration of conformity and as needed work with Authorized Representative (EU) on country notifications and registrations.
· Participate as the regulatory representative on project teams and new product launches to provide guidance and direction on regulatory requirements.
· Provide guidance and review of product labeling, promotional material, change control and other related product documentation as needed.
· Assist with internal audits and audits from external regulatory bodies.
· Support maintenance of the company's Medical Device Listing and Device Establishment registration forms.
· Recommend modification to internal guidelines, work instructions, and procedures. Draft Regulatory procedures and support updates to other Quality System procedures as needed.
· Support cross functional sites and other Biotelemetry business (as applicable) with regulatory needs
· Lead Regulatory Projects as needed
· Education: Bachelor’s degree in Science or Engineering
· Relevant Work Experience: 5-10 years’ experience in Regulatory/Quality in the medical device field, experience with software as medical devices (desirable)
· Licenses/Certifications: N/A
Required Knowledge, Skills, and Abilities
· Knowledge/Abilities –Technical Skills: General IT skills; Microsoft Office/Outlook, etc. Strong knowledge and application of 21 CFR 820, ISO 13485, EU MDR/MDD, IEC 62304
· Communication Skills (Verbal/Written): Excellent communication skills, ability to communicate and work at all levels of the organization. Strong technical writing skills
· Management/Leadership Skills: Ability to lead regulatory projects
· Customer Service: Ability to work well with external and internal customers with regulatory requests
· Other: Ability to work in a flexible, dynamic work environment