Job ID: 10832
Affymetrix, now part of Thermo Fisher Scientific
Quality Assurance Analyst
Based in San Diego, CA
We are seeking a highly motivated Quality Assurance Analyst who will be responsible for performing various activities pertaining to ensuring compliance with applicable regulatory requirements. These activities may include Validation, Customer Complaints, Review of records related to product manufacture, Audits, and QA documentation. Assists in maintaining systems to ensure that all products meet ISO and FDA regulations.
Essential Duties and Responsibilities include the following (other duties may be assigned.):
* Utilizeing basic understanding of US and global regulations for medical device products. Maintain awareness of global regulatory requirements on medical device industry
* Actively contributes in planning for and preparation of regulatory submission documents for US and global regulatory filings.
* Manage the California State Licensing program and all other associated regulatory licenses and/or documentation required.
* Manage facility registration and renewal process
* Participate as an active team member and provide regulatory advice to project teams as required
* Contribute in writing responses to inquiries from regulatory authorities and interact with regulators during inspections. Maintain regulatory files in a format consistent with requirements
* Support routine regulatory activities including change assessments, review of specifications, validation protocols, and deviations.
* Support Site Operations involved in FDA inspections and partner audits including ISO and FDB audits as well as tracking of commitments affecting regulatory compliance
* Demonstrate strength and ability to work effectively and flexibly with multiple disciplines and personalities.
* Strong communicating skills are required for successful interactions with teams, partners, and regulatory agencies to facilitate review and approval of submissions.
* A high level of professionalism, efficiency, and commitment.
* Effective problem solving, strong understanding of regulatory affairs, excellent interpersonal skills and the ability to prioritize multiple tasks and work under time pressure.
* BS degree in Chemistry, Biology or related scientific discipline, advanced degree preferred
* 5 years medical device industry experience and a minimum of 3 years in Regulatory Affairs required
* Experience in using MS office tools
* Outstanding interpersonal and communication skills
Physical Demands and Work Environment:
The physical demands and work environment described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
While performing the duties of this job, the employee is regularly required to sit, stand, walk, talk and hear; use hands to finger, handle or feel; and reach with hands and arms.
The noise level in the environment is usually moderate.
Affymetrix is an EEO/AA Employer of Minorities/Females/Veterans/Disability/Sexual Orientation and Gender Identity.