Regulatory Compliance Specialist for Medical Devices

Advantage Resourcing
Published
May 29, 2021
Location
San Jose, CA
Category
Job Type

Description

Regulatory Compliance Specialist for Medical Devices

Responsible for regulatory compliance who has the requisite expertise in the field of medical devices. The requisite expertise shall be demonstrated by either of the following qualifications:

Diploma, certificate or other evidence of formal qualification, awarded on completion of a university degree or of a course of study recognized as equivalent in law, medicine, pharmacy, engineering or another relevant scientific discipline, and at least one year of professional experience in regulatory affairs or in quality management systems relating to medical devices; or

Four years of professional experience in regulatory affairs or in quality management systems relating to medical devices.

Responsible for regulatory compliance shall be responsible for ensuring that:

Conformity of the devices is appropriately checked, in accordance with the quality management system under which the devices are manufactured, before a device is released;

 Technical documentation and the EU declaration of conformity are drawn up and kept up-to-date;

Post-market surveillance obligations are complied with in accordance company requirements. 

Similar regulatory requirements for compliance with the FDA.

Required:

  • Medical Device Reporting (MDR) experience required
  • Understanding of Regulations for European Union sale of medical devices
  • Knowledge of Regulatory Government Affairs new regulations for conducting business related to medical devices in the EU
  • Looking for candidates with high energy and passion for the field. 
  • 4+ years experience in regulatory affairs or quality management systems related to medical devices. 

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About Advantage Resourcing

Advantage Resourcing is committed to providing equal employment opportunity for all persons regardless of race, color, religion (including religious dress and grooming practices), sex, sexual orientation, gender, gender identity, gender expression, age, marital status, national origin, ancestry, citizenship status, pregnancy, medical condition, genetic information, mental and physical disability, political affiliation, union membership, status as a parent, military or veteran status or other non-merit based factors. We will provide reasonable accommodations throughout the application, interviewing and employment process. If you require a reasonable accommodation, contact us. Advantage Resourcing is an E-Verify employer. This policy is applicable to all phases of the employment relationship, including hiring, transfers, promotions, training, terminations, working conditions, compensation, benefits, and other terms and conditions of employment.

All employees are directed to familiarize themselves with this policy and to act in accordance with it. All decisions with respect to employment matters and other phases of employer-temporary employee relationships will be in keeping with this policy and in accordance with all applicable laws and regulations.

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