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Regulatory Specialist I in Arden Hills, MN at APEX Systems

Date Posted: 3/15/2019

Job Snapshot

Job Description

Job #:  941472

Apex Systems is seeking a Regulatory Specialist to work with a prominent medical device and pharmaceutical company in Arden Hills, MN. This is an excellent opportunity for someone with a commitment to wot kin in the quality division of a medical device company. Ideal candidates will be quick learners with strong organizational and critical thinking skills. Familiarly with MDR or MedWatch and/or Vigilance is a HUGE PLUS!

 

For immediate consideration, please email updated resumes to KMooney@apexsystems.com 

 

Job Description:

Review complaint communications and assess for regulatory compliance, reportability, and potential impact to patient safety and business operations.

Responsibilities:

• Participate in development and modification of these decision models with changes in product advances/therapies to uphold consistent compliance with government-mandated regulations.

• Evaluate and investigate identified complaints by gathering sufficient data from clinical staff, field representatives, internal employees, and laboratory analysis

• Collect, compile, and document regulatory reportability decisions using event investigation and regulatory decision models.

• Draft Medical Device Reports (MDRs), MedWatch, Vigilance, and other regulatory reports, ensuring timely transition to the appropriate regulatory authorities.

• Apply codes to events to facilitate product performance records.  Review coding and investigations with engineering, laboratory, and other internal staff.

• Draft written communications detailing the clinical observation, investigation and/or product analysis, and corrective actions, as applicable, to physician and other end use customers.  Communications include determination/eligibility for warranty credit or unreimbursed medical payments.

Basic Qualifications:

• Bachelor’s Degree

• 2 - 4 Years’ experience with BS

• 0 - 2 Years’ experience with MS

• Proficiency with computer programs including, but not limited to: Microsoft Office (Excel, Word, Access, Outlook)

Preferred Qualifications:

• Prior experience within complaint or regulatory handling

• Experience in medical device or healthcare industry – clinical knowledge is preferred

• Strong organizational skills

• Critical thinking skills

 

 

 

 

 

 

 

 

EEO Employer

Apex is an Equal Employment Opportunity/Affirmative Action Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, age, sexual orientation, gender identity, national origin, disability, protected veteran status, or any other characteristic protected by law. Apex will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require an accommodation in using our website for a search or application, please contact our Employee Services Department at 844-463-6178