Regulatory Affairs Specialist

1 month ago

Carlsbad, United States Internetwork Expert Inc Full time

ATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; as well as the support of daily activities related to product design teams, change control, and regulatory product submissions. Essential Duties and Responsibilities Collaborates

as a core team member on new product development teams. Determines and

documents appropriate regulatory strategy for proposed new products.

Supports design control activities. Supports

and assists in FDA 510(k) premarket notifications and ROW regulatory

submissions. Coordinates responses to regulatory agencies as part of the submission and approval process. Evaluates design changes to products to determine impact to submissions and potential need for additional submissions. Assists

with post-market surveillance evaluation, trending, and reporting,

including updates to risk management (FMEA) process. Reviews

and approves labeling and promotional materials for compliance with

applicable regulations and policies. Researches

sources of regulatory information (e.g., regulatory agency websites,

standards organization websites, literature, trade sheets, competitor

information, etc.). Provides

department support during internal and external audits. Develops

and maintains procedures and/or work instructions for product

registrations. Maintains

FDA establishment listings and registration. Other

duties as assigned. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

Typically requires a bachelor’s degree and 2-3 years of experience in the medical device industry. Strong knowledge of FDA Quality System Requirements (QSR) and ISO 13485. RAC Certification is preferred. Orthopedic

or spine experience preferred. Must

be detail oriented and have strong technical writing skills. Must

possess strong interpersonal communication, teamwork and organizational

skills. Education and Experience

Must have a Bachelor’s degree in Engineering or Biological Science. A minimum of two to three years in an FDA-regulated environment. For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable). ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws. Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws. Salary Range Alphatec Spine, Inc. complies with state and federal wage and hour laws and compensation depends upon candidate’s qualifications, education, skill set, years of experience, and internal equity. $92,600 to $112,700 Full-Time Annual Salary/Hourly Range

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