Regulatory Compliance Specialist

7 days ago

Carlsbad, United States Orthofix Full time
About Orthofix

At Orthofix, we are guided by our organizational values of Take Ownership, Innovate Boldly, and Win Together. We collaborate closely with world-class surgeons and other partners to improve people's quality of life. Our global team of over 1,600 employees brings to market highly innovative, cost-effective, and user-friendly medical technologies that heal musculoskeletal pathologies for patients and the healthcare professionals who treat them.

Salary and Benefits

The anticipated base hourly rate for this position is $28.25 to $36.96 per hour, plus bonus, and benefits. The final pay offered to a successful candidate will be dependent on several factors including but not limited to the type and years of experience within the job, the type and years of experience within the industry, education, etc.

Job Description

This is an exciting opportunity for a Document Control Specialist to join our team. As a subject matter expert, you will coordinate document control activities related to the document management and data management systems. This position is also responsible for interfacing with all departments to organize, maintain and edit documentation in support of products and quality system processes.

  • You will coordinate the activities of Document Control, including the tracking, release, distribution, and auditing of controlled documents.
  • You will organize and facilitate approval process of Change Orders, including distribution and archiving of final documents whether hard copy or electronic.
  • You will review completeness of documentation for accuracy and consistency.
  • You will maintain compliance activities associated with the Quality Management System (QMS) to comply with applicable regulations.
  • You will reviewing completeness and processing of deviations.
  • You will collaborate with subject matter experts effectively to prepare controlled documents per our GDP procedures.
  • You will managing GTIN Database.
  • You will compilation of monthly document control metrics.
  • You will effectively follow SOPs, policies, and FDA Good Manufacturing Practices.
  • You will provide support for the Quality Systems and Regulatory departments during internal and external audits and actively participate in department activities.
  • You will support the CAPA program as needed.
  • You will scan, file and/or box documentation (i.e., batch records, Special Request etc.) and verify documentation for destruction, per our established procedure as applicable per site.
  • You will maintaining External Standards and processing of requests for updates or new purchases.
Required Skills and Qualifications

To be successful in this role, you will need:

  • A minimum of 3+ years' experience within Document Control.
  • Related experience working with Quality System or technical documentation systems, preferably in an FDA regulated environment.
  • Working knowledge of ISO and FDA document management guidelines, regulations, and standards.
  • Outstanding attention to detail.
  • Strong interpersonal skills and ability to work with others in a positive and collaborative manner.
  • Demonstrated ability to work accurately, follow instructions/schedules/timelines and handle multiple priorities.
  • Ability to utilize multiple word-processing and database applications including MS Office applications Word, Excel, and other software applications as necessary.
Bonus Information

We are committed to providing equal employment opportunities to all employees and applicants without regard to race, ethnicity, religion, color, caste, sex, gender, gender identity or expression, sexual orientation, national origin, ancestry, citizenship status, uniform service member and veteran status, marital status, pregnancy, age, protected medical condition, genetic information, disability, reproductive health decision-making, medical leave or other types of protected leave, domestic violence victim status, political affiliation, or any other protected status in accordance with all applicable federal, state, and local laws.

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