Sr. Regulatory Specialist

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  "active_status": "active"
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  "location": {
    "raw": "Gainesville, FL, Gainesville, Florida",
    "city": "Gainesville",
    "region": "FL",
    "country": "United States",
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    "confidence": 0.9
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      "city": "Gainesville",
      "region": "FL",
      "country": "United States",
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{
  "id": "521656",
  "job": {
    "id": "527507",
    "division": {
      "id": "210",
      "name": "Advita Ortho"
    },
    "department": {
      "id": "11428",
      "name": "Regulatory"
    },
    "requisition_id": "EXAC0862",
    "structure_custom_group_one": null
  },
  "url": "https://advitaortho.pinpointhq.com/en/postings/0fe5739b-5f34-4fff-8687-6605841412f2",
  "path": "/en/postings/0fe5739b-5f34-4fff-8687-6605841412f2",
  "title": "Sr. Regulatory Specialist",
  "benefits": "",
  "location": {
    "id": "5732",
    "city": "Gainesville",
    "name": "Gainesville, FL",
    "province": "Florida",
    "postal_code": "32653"
  },
  "deadline_at": null,
  "description": "<div><!--block-->&nbsp;The purpose of the Senior Regulatory Specialist is to provide services to fulfill the regulatory requirements necessary to achieve global regulatory approvals / clearances and maintain overall regulatory compliance for the company.&nbsp;</div>",
  "compensation": null,
  "reporting_to": "Sr. Manager Regulatory Affairs",
  "workplace_type": "onsite",
  "benefits_header": "",
  "employment_type": "full_time",
  "workplace_type_text": "Onsite",
  "compensation_maximum": null,
  "compensation_minimum": null,
  "compensation_visible": false,
  "employment_type_text": "Full Time",
  "key_responsibilities": "<ul><li><!--block-->&nbsp;With minimal oversight, preparing and maintaining pre-market submissions or post-market change submissions for a variety of markets.&nbsp;</li><li><!--block-->With minimal oversight, provide project-level regulatory strategy and support for new product development projects, postmarket lifecycle projects, Quality System updates, business development projects:<ul><li><!--block-->&nbsp;Project team RA lead member&nbsp;</li><li><!--block-->&nbsp;Assess and approve post-market changes&nbsp;</li><li><!--block-->Assess and approve product and process Nonconformances and deviations&nbsp;</li><li><!--block-->Own and execute CAPA for Regulatory processes&nbsp;</li></ul></li></ul>",
  "compensation_currency": null,
  "compensation_frequency": null,
  "skills_knowledge_expertise": "<div><!--block--><strong>Education:</strong></div><ul><li><!--block-->Bachelor’s Degree from an accredited institution required</li></ul><div><!--block--><strong>&nbsp;Experience:</strong></div><ul><li><!--block-->&nbsp;Minimum 5 years experience in FDA/ISO medical devices quality management system standards required&nbsp;</li><li><!--block-->5 years experience in FDA pre-market submissions (510(k) and/or PMA) and international product registrations required&nbsp;</li></ul><div><!--block--><strong>Functional/Technical Knowledge, Skills and Abilities Required:</strong></div><ul><li><!--block-->&nbsp;Technical writing skills required&nbsp;</li></ul><div><!--block--><br></div>",
  "key_responsibilities_header": "Key Responsibilities",
  "skills_knowledge_expertise_header": "Skills Knowledge and Expertise"
}