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Regulatory Affairs Manager

Santa Clara, CA 95050

Posted: 05/24/2023 Employment Type: Direct Hire/Perm Job Category: Regulatory Sciences and Medical Writing Job Number: 554548 Is job remote?: No Country: United States

Job Description

Regulatory Affairs Manager Salary: $130k-$160k for Bay Area Candidates onsite

General Responsibilities

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.

Specific Responsibilities
  • 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
Qualifications And Experience
  • 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

The staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at Planet Pharma.

Planet Pharma and The Planet Group of Companies are equal opportunity employers. It is our practice not to discriminate against any employee or applicant based on any criteria, condition or basis protected by laws or regulations in the locations where we do business. All qualified applicants are encouraged to apply. We celebrate diversity and are committed to providing an environment of mutual respect. We believe that diversity, equity and inclusion enable us to better meet our mission and values while serving our clients across the globe. If you have a disability or handicap and would like us to accommodate you in any reasonable way, please inform your recruiter, or contact us, so that we can discuss the appropriate alternatives available.

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Although this hasn't been an issue at The Planet Group, the staffing industry has seen an increase in people falsely representing themselves as recruiters to gather personal information from job seekers. For your safety, do not provide sensitive data to anyone you have not spoken with thoroughly and never provide banking information during the application process. Candidate safety is a top priority at The Planet Group.

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