Specialist, Regulatory Compliance

Michael Page

Job Description

MPI does not discriminate on the basis of race, color, religion, sex, sexual orientation, gender identity or expression, national origin, age, disability, veteran status, marital status, or based on an individual's status in any group or class protected by applicable federal, state or local law. MPI encourages applications from minorities, women, the disabled, protected veterans and all other qualified applicants.

Summary

Serve as a liaison between the company and the regulatory bodies and Perform regulatory compliance safety rounds/checks to guarantee continuous regulatory compliance as directed.

Client Details

Our client is a medical device manufacturer founded on great values. Since 2004, they have established a national presence with its small business ethos: high quality products can be affordable, and personalized service is invaluable.

Description

The major duties, tasks, and responsibilities that commonly make up the regulatory compliance specialist job description are listed below:

  • Serve as a liaison between the company and the regulatory bodies
  • Perform regulatory compliance safety rounds/checks to guarantee continuous regulatory compliance as directed
  • Relate with all levels of employees to discuss regulations, standards, and company policies with the aim of providing education as needed
  • Responsible for the review of incident data and carry out root cause analysis to ascertain the cause
  • Offer assistance with the department newsletter and perform additional administrative and reporting duties as assigned
  • Review and evaluate the company's products/services to ensure compliance with relevant regulations, standards of identity, and claim requirements
  • Communicate up-to-date knowledge of current US and relevant international regulations that concern the operations of the company to internal partners
  • Responsible for answering compliance-related questions to provide regulatory guidance regarding the products/services of the company, in accordance with emerging/new regulations
  • Conduct research to provide appropriate compliance recommendations, advice on upcoming regulations, and evaluating the overall impact on the business.

Profile

  • Education: To work as a regulatory compliance specialist, applicants are commonly required to have minimum of Bachelor's degree. However, an advanced degree is preferred
  • Knowledge: 3+ years of practical experience as regulatory compliance specialist.
  • They should also possess impeccable knowledge of regulation and be skillful in enforcing the rules. To do this, he/she is expected to be conversant with rules. This is accrued through years of training onsite and offsite
  • They should have investigating, auditing, and interviewing skills. Successful regulatory compliance specialists are highly analytical and are detail-oriented. It is crucial that they can unravel hidden records of the company as well as tactfully ask helpful or meaningful questions that are capable of producing the desired results from both the employer(s) and the employees
  • Teamwork skills: Applicants may be required to provide education to employees in teams. So it is important that they can work in a team oriented environment

Job Offer

  • Ability to work with Tier 1 and 2 Medical Devices
  • Comprehensible benefits and competitive market salary
  • 4 weeks PTO
  • 401K Match
  • Opportunity to implement change as you see fit with the support of management

Job Requirements

The major duties, tasks, and responsibilities that commonly make up the regulatory compliance specialist job description are listed below:

Serve as a liaison between the company and the regulatory bodies
Perform regulatory compliance safety rounds/checks to guarantee continuous regulatory compliance as directed
Relate with all levels of employees to discuss regulations, standards, and company policies with the aim of providing education as needed
Responsible for the review of incident data and carry out root cause analysis to ascertain the cause
Offer assistance with the department newsletter and perform additional administrative and reporting duties as assigned
Review and evaluate the company's products/services to ensure compliance with relevant regulations, standards of identity, and claim requirements
Communicate up-to-date knowledge of current US and relevant international regulations that concern the operations of the company to internal partners
Responsible for answering compliance-related questions to provide regulatory guidance regarding the products/services of the company, in accordance with emerging/new regulations
Conduct research to provide appropriate compliance recommendations, advice on upcoming regulations, and evaluating the overall impact on the business.

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