Bachelors degree in a scientific discipline or a related field.
At least 2 years of previous work experience in a similar regulatory position
Solid knowledge of regulatory requirements for Class II medical devices.
Strong understanding of FDA Quality System Regulations (cGMP) and related international standards for medical devices, including 21 CFR Part 820.
Knowledge of ISO 13485 and ISO 14971 standards and their application to medical device quality and risk management systems.
Familiarity with basic laboratory equipment and analytical instrumentation relevant to medical device development and testing.
Proficiency in Microsoft Word, Excel, and Outlook for preparing documents, reports, and correspondence.
Ability to use web browsers such as Internet Explorer, Chrome, or Firefox to research regulatory information and access online systems.
Internal audit experience related to regulatory compliance or quality systems.
Ability to read, analyze, and interpret business periodicals, professional journals, technical procedures, technical journals, and governmental regulations in English.
Ability to write clear and comprehensive regulatory submissions, reports, business correspondence, and procedure manuals in English.
Mathematical skills, including the ability to calculate figures such as discounts, interest, proportions, percentages, area, circumference, and volume, and apply basic algebra and geometry.
Ability to work with mathematical concepts such as probability and statistical inference.
Reliable attendance and punctuality
Valid drivers license with a satisfactory driving record.
Experience preparing and managing regulatory submissions for domestic and international markets.
Experience interacting directly with regulatory agencies on pre-submission strategies, submission reviews, and follow-up inquiries.
Ability to interpret and apply guidance documents, international standards, and consensus standards to product and process requirements.
Experience reviewing product labeling, promotional materials, batch records, and test methods for regulatory compliance.
Experience with ISO-based quality management systems, particularly ISO 13485 for medical devices.
Familiarity with risk management practices aligned with ISO 14971.
Knowledge of FDA Quality Systems regulations and broader regulatory frameworks related to medical devices.
The role involves regular periods of sitting, standing, and walking, as well as frequent use of hands to handle documents and operate office equipment such as computers, copiers, scanners, fax machines, and telephones.
Occasional reaching with hands and arms, stooping, kneeling, or crouching may be required, along with occasionally lifting or moving items up to 10 pounds.
Visual requirements include close vision, peripheral vision, depth perception, the ability to adjust focus, and color vision to review detailed documentation and product materials.