At ACON labs, we are making a difference in medical care by offering medical devices for diagnosing a variety of conditions. In addition, we are able to streamline and reduce costs for the physician and/or patient directly. Come join us in developing the latest technologies that enhance human life and be a part of our growing, dynamic company.
We are looking for a Regulatory Affairs Specialist to join the Regulatory Affairs team. The Regulatory Affairs Specialist is responsible for encompassing the support of worldwide product registrations and support of Regulatory activities, coordinates the accumulation of technical information and prepares submissions for therapeutic, medical, or diagnostic device licenses to various governmental regulatory agencies by performing the duties including but not limited to below.
Essential Duties and Responsibilities
Assists in preparing, submitting and maintaining regulatory filings with relevant health authorities;
Participates in new product development core teams and creating of Regulatory Strategies, and representing RA function group participation of products design phase review from I to V and provide regulatory consideration to the design team regard to design RA requirement and guidance document;
Maintains country specific site registration requirements;
Assists in preparing documentation for product incident reporting as required;
Maintains current regulatory knowledge by attendance at regulatory seminars and meetings;
Maintains current regulatory databases to produce various reports as needed
Review labeling, package inserts, promotional materials and company website to meet the FDA regulatory requirements;
Maintain Essential Requirements Checklists- ensuring that applicable standards are utilized and updated as revisions are introduced;
Compile Technical Documentation for historical files
Assist OEM customer in obtaining the CE mark on their products
Education and/or Experience
Bachelors in related discipline or equivalency.
Minimum 3 years industry experience with a minimum 0-3 years experience in preparation and submission of 510k and CE technical files;
Required Knowledge, Skills and Abilities
Knowledge of QSRs & ISO 13485; and IVDD, MDD, CMDR, GMP, and 21 CFR.
Strong working knowledge of medical devices regulations and terminologies
Excellent written and oral communication, and technical writing and editing skills
Ability to write clear, understandable technical documentation
Skilled at analyzing and summarizing data.
Proficient with Microsoft Office
Ability to manage and prioritize multiple projects
Ability to follow written and verbal direction with a high level of accuracy
Ability to work in a team setting
This position is located in our corporate offices in San Diego’s biotech community. As an employee, you’ll enjoy our competitive benefits and compensation packages. We invite you to consider a career with ACON Laboratories by submitting your resume.
Please reference job code RA021 and your name in the subject line in the email. (Example: RA021 – Smith, John).