Regulatory Compliance Specialist

1 month ago

Saint Paul, Minnesota, United States Murata Electronics Full time


Regulatory Compliance Specialist

Location:

US



Murata Viosis a global medical device company dedicated to creating a paradigm shift in the way healthcare is delivered. Through the utilization of our internet-of-things medical-grade sensors and virtual patient care services, we plan to lower the cost of healthcare and improve patient outcomes. Murata Viosis seeking qualified individuals who contribute to our vision through sound product development engineering practices and passionate sales and marketing leadership.

Why Consider This Job Opportunity

The Regulatory Compliance Specialist supports the regulatory submission team in preparation of regulatory submission packages at Murata VIOS. The position will ensure that submission packages are prepared in accordance with applicable laws, international standards, and regulatory guidance documents. The Regulatory Compliance Specialist is responsible for maintaining records of regulatory submissions including interactions with regulatory bodies and routing them for approval in the Quality Management System. In addition to providing technical support for regulatory submissions, this role will monitor changes to regulations and international standards that affect Murata VIOS devices.

Workplace Policy

Hybrid from Woodbury, MN.

What To Expect (Essential Job Responsibilities)
  • Develops procedures and workflows that ensure that regulatory submission packages are complete and comply with currently accepted consensus standards and guidance documents.
  • Identify the owners of and manage the deliverables for regulatory submissions, Additional Information Notifications (AINNs), and other regulatory interactions.
  • Maintain websites for regulatory site registration, device listings, Global Universal Device Identifier Directory (GUDID), etc.
  • Monitor the release of new regulatory guidance documents and act as a Subject Matter Expert (SME) for guidance documents.
  • Provide regulatory support for device labeling changes.
  • Document and submit minutes of meetings with regulatory authorities; document regulatory decisions and add to DHF/QMS.
Miscellaneous Job Responsibilities
  • Cross-training in Quality processes such as NCP (Nonconforming Product), CAPA (Corrective Action & Preventive Action), Internal Audits, Complaint Handling, and Change Order Processing.
  • Supports and manages projects as directed by the Director, Quality, Regulatory & Compliance.
  • Thorough understanding of FDA regulations and strong working knowledge of medical devices, procedures, and terminology. Working knowledge of product realization process and design control.
What Is Required (Qualifications)
  • Bachelor's Degree.
  • 2+ years' experience in a regulatory department.
  • Strong written and oral English communication skills.
How To Stand Out (Preferred Qualifications)
  • Masters' Degree.
  • 2+ years' experience with a medical device manufacturer is highly preferred.
  • Ability to multitask, support and manage multiple projects, function on a global basis, prioritize, and meet project deadlines.
  • Experience with regulatory filings such as FDA 510(k).
  • Proficiency with Microsoft Office Suite, Adobe Acrobat, FDA eSTAR.

Create a better life for patients, clinicians, and hospital administrators by joining the Murata Viosteam. Murata Viosoffers competitive compensation and comprehensive benefits.

Equal Opportunity/Affirmative Action Employer - M/F/Disabilities/Veterans







pSemi Corporation supports a diverse workforce and is committed to a policy of equal employment opportunity for applicants and employees. pSemi does not discriminate on the basis of age, race, color, religion (including religious dress and grooming practices), sex/gender (including pregnancy, childbirth, or related medical conditions or breastfeeding), gender identity, gender expression, genetic information, national origin (including language use restrictions and possession of a driver's license issued under Vehicle Code section , ancestry, physical or mental disability, legally-protected medical condition, military or veteran status (including "protected veterans" under applicable affirmative action laws), marital status, sexual orientation, or any other basis protected by local, state or federal laws applicable to the Company. pSemi also prohibits discrimination based on the perception that an employee or applicant has any of those characteristics, or is associated with a person who has or is perceived as having any of those characteristics.

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