Regulatory Affairs Manager
471 El Camino Real Santa Clara, CA 95050 US
Prepare regulatory submissions to support product commercialization (e.g. 510(k), CE Mark Technical File, International). Maintain existing approvals/clearances and documentation. Manage Regulatory Affairs resources as assigned. Manage projects to compliment key strategic and commercial initiatives.
In the event of potential non-compliance with applicable standards or regulations (e.g. FDA QSRs, ISO 13485, ISO14971, IEC 62366), the employee has the authority to hold any product or QA/RA documentation from shipment or further processing. The employee has the responsibility to report any instances to their direct supervisor or above.
The employee must at all times act and conduct business in an honest, ethical and strictly legal manner, complying with the Code of Conduct, other company policies, the AdvaMed Code and all applicable laws and regulations, whether national, regional, state or local.
- Support New Product Development on project teams on behalf of RA, developing and implementing Regulatory strategies and deliverables for US, EU and International (OUS)
- In conjunction with Head of Regulatory, responsible for communication and correspondence with DEKRA (Notified Body), FDA, and other Regulatory bodies (competent authorities)
- Prepare Regulatory submissions such as US PreSubmissions, IDE’s, 510(k)s and Letter-to-File; and EU / OUS Declarations of Conformity, Technical Files (STEDs), Notice of Changes for new products and product changes
- Review product changes for impact on current clearances and approvals
- Implement new regulations and changes to US and global Regulatory requirements (e.g. EU MDR)
- Attend internal and external audits/inspections in a Regulatory capacity and address any issues or concerns, and support the Quality System Management Representative, as appropriate
- Facilitate communication, Regulatory-related remediations, and written audit responses to the responsible regulatory agency
- Oversee labeling, including product labels, implant cards, IFUs, surgical technique manuals, cleaning and sterilization instructions, etc., ensuring compliance to standards, guidelines, regulations, company requirements, and regulatory approvals/clearances. Ensures translations have been performed per in country requirements.
- Communicate with RA consultants (e.g. Emergo), Authorized Representative and sometimes directly with International regulatory bodies (competent authorities) to obtain approvals and manage registrations
- Monitor and obtain information regarding FDA clearances/approvals of competitors and proactively share information
- Support Regulatory-related activities for Sustaining Operations, including product changes, supplier changes, CAPAs, Deviations, NMRs, and extension/scope changes
- Write and/or review Quality Manual, SOPs, WIs, Forms that impact the QMS
- Support Company QMS
- Bachelor’s degree in a scientific discipline
- 8+ years of directly relevant experience with a minimum of 5 years of recent experience in FDA/cGMP/CE Mark or other regulated environment(s)
- Knowledge of industry standards and regulations (FDA, QSRs, MDR ISO 13485, MEDDEV, MDCG etc.)
- Experienced in Quality System requirements such as Design Control, Production Process Controls, Supplier Controls, Corrective and Preventive Action, and Non-Conformances
- Regulatory experience within the medical device industry preparing PreSubmissions, 510(k)s submissions and STEDs is required
- Strong oral, written, organizational and computer skills, including Microsoft Office Suite (Word, PowerPoint and Excel) and Adobe Acrobat (for FDA E-copies)
- Thorough understanding of FDA and international medical device regulations, product development process and design control requirements
- Ability to work independently with minimal supervision and manage multiple projects
- Must be a team player
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