Senior Post Market Surveillance Specialist

Pure Global; Burnsville (MN); On-site; USD 110,000 - 132,000; Full time

Benefits offered by this job

Medical insurance

Dental insurance

Vision insurance

Health Savings Account (HSA)

Health Care & Dependent Care FSA

Disability benefits

Life Insurance

Retirement benefits

Job summary

Pure Global in Burnsville, MN is seeking a Post Market Surveillance Specialist to support all post market activities. You will interact with Regulatory and Engineering teams on complaint analysis, investigation, and reporting and ensure compliance with the Imricor Quality Management System.

Responsibilities include filing global medical device reports within regulatory timeframes, leading product complaint investigations, conducting post market trend analyses, and supporting regulatory

Qualifications

• Bachelor’s degree in applicable field.
• 5+ years’ experience in Post Market Surveillance or related field.
• Must be able to work independently under limited supervision.
• Knowledge of global regulations for medical device reporting and complaint handling.
• Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
• Strong communication skills, both verbal and written.

Responsibilities

• Assists Regulatory team in ensuring all global medical device reports are filed within regulatory timeframes.
• Provides training on complaint reporting to other groups.
• Performs and presents post market trending analysis.
• Ensures timely processing of complaints and maintains complaint database.
• Collaborates independently with other departments and leads product complaint investigations.
• Supports inspections by regulatory agencies (e.g. FDA, TUV) as requested.
• Makes sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management.
• Uses procedures, judgement, and experience to determine appropriate testing of returned products with minimal guidance.
• Conducts investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
• Authors post market surveillance plans/reports and periodic safety update reports (PSUR).
• Performs other related duties and responsibilities, as assigned.

Skills

Independent work

Communication skills

Analytical thinking

Education

Bachelor's degree

Job description

Description

Supervisor’s Title: Director of Quality

Exempt or Non-Exempt: Exempt

Location: Must be available to work at our location in Burnsville, MN.

Compensation: The expected annual base salary range for this Minnesota-based position is $110,000-132,000. This range represents a good faith estimate for this position. The specific compensation offered to a candidate may vary based on factors including, but not limited to, the candidate’s knowledge, skills, and or experience. In addition, this position may be eligible for a range of benefits (e.g., Medical, Dental, Vision, Health Savings Accounts, Health Care & Dependent Care Flexible Spending Accounts, Disability Benefits, Life Insurance, and Retirement Benefits).

Basic Function

This post market surveillance specialist position supports all post market surveillance activities. This position interacts closely with the Regulatory and Engineering teams in complaint analysis, investigation, and reporting as applicable. This position is responsible for complying with the Imricor Quality Management System requirements and carrying out responsibilities as outlined in the environmental, health, and safety policies.

Essential Functions:

• Assists Regulatory team in ensuring all global medical device reports are filed within regulatory timeframes.
• Provides training on complaint reporting to other groups.
• Performs and presents post market trending analysis.
• Ensures timely processing of complaints and maintains complaint database.
• Collaborates independently with other departments and leads product complaint investigations.
• Supports inspections by regulatory agencies (e.g. FDA, TUV) as requested.
• Makes sound decisions regarding medical device reporting to various global regulatory agencies, minimizing the need for input from department management.
• Uses procedures, judgement, and experience to determine appropriate testing of returned products with minimal guidance.
• Conducts investigations with customers or field staff with minimal direction, utilizing experience and knowledge of products and various types of product complaints
• Authors post market surveillance plans/reports and periodic safety update reports (PSUR).
• Performs other related duties and responsibilities, as assigned.

Requirements

Qualifications:

• Bachelor’s degree in applicable field.
• 5+ years’ experience in Post Market Surveillance or related field
• Must be able to work independently under limited supervision.
• Knowledge of global regulations for medical device reporting and complaint handling.
• Experience with European Medical Device Regulations, FDA 21 CFR Regulations, Australian TGA Regulations, ISO 14971, ISO 13485.
• Strong communication skills, both verbal and written.

Working Conditions

• Light work, exerting up to 20 lbs. of force or less.
• Requires clarity of vision at 20 inches or less (near vision) and ability to identify/distinguish colors.
• Requires typing, talking and hearing.
• Travel <10%

The statements above reflect the principal function and most significant duties of the job as necessary for its evaluation in relation to other jobs in the organization and shall not be construed as a detailed description of all the work requirements that may be inherent in the job. Any functions that are non-Essential will be identified as such above. A request for Reasonable Accommodations may be made to enable qualified individuals with disabilities to perform the essential functions.