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Job Title:
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Regulatory Affairs Associate
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Location:
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Mountain View |
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Purpose of Job:
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Under supervision, Associate/Specialist will plan, support and implement activities necessary to obtain and maintain regulatory approvals inside and outside of the United States. Associate/Specialist will oversee ongoing regulatory compliance, participate in cross functional teams to advise on regulatory strategy, and coordinate department organizational activities. |
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Major Duties and Responsibilities
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Collaborate with regulatory affairs management to develop regulatory strategies, and ensure the timely and accurate completion of all assigned regulatory projects and submissions.
Prepare and maintain IDE, 510(k), PMA, international design dossiers and related regulatory filings.
Create and implement departmental procedures to facilitate compliance to all US and international requirements and corporate policies and procedures.
Assist with medical science data analysis and clinical research activities.
Proactively support company goals and objectives, policies and procedures, and Good Manufacturing Practices (GMP). Ensure compliance with Quality System Regulations (QSR), ISO 13485, MDD and other applicable standards and regulatory requirements.
Review marketing documents to ensure compliance with all labeling/advertising and promotion guidance and regulations.
Assist Product Surveillance in making reporting decisions for medical complaints.
Serve as regulatory affairs representative on various project teams.
Monitor external global regulatory environment and integrate relevant changes into department and corporate processes and procedures.
Maintain knowledge of competitive technologies including scientific, clinical and regulatory developments, and literature related to Conceptus’ technologies and products.
Perform other duties as assigned.
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Education Requirements:
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Bachelor’s degree or an equivalent combination of education and work experience. |
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Experience Requirements
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Minimum two to four years of related experience in the medical device industry with at least one year of regulatory affairs experience (Associate), or at least four years regulatory experience (Specialist). |
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Other Qualifications:
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Thorough working knowledge of Class III medical device environment with experience submitting PMA supplements preferred. |
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This job has already been filled. Thank you for your interest.
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