Sr. Specialist, Regulatory Affairs

The Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.

Essential Duties and Responsibilities

• Collaborates as a core team member on new product development teams. Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities. Provides regulatory input to project timeline planning.
• Prepares regulatory submissions including 510(k) premarket notifications for US FDA
• Prepares regulatory submissions including technical files/design dossiers for registration of products in MDSAP countries and interfaces as needed with Notified Bodies regarding significant changes to products.
• Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
• Critically reviews verification and validation reports, and other documents for scientific merit and to ensure adherence to regulatory requirements.
• Assists with post market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process.
• Reviews product labeling and promotional materials to ensure consistency with regulatory approvals/clearances.
• Reviews nonconformances and deviations and provides regulatory guidance and expertise.
• Provides mentorship to less senior regulatory team members.
• 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.
• Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.
• Maintains FDA establishment listings and registration.
• Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, 21 CFR 820, 21 CFR 1271, global medical device registration, technical writing, and external standards.
• Other duties as assigned.

Requirements

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 in a STEM field and five years of experience in regulatory affairs in the medical device industry.
• Strong knowledge of FDA Quality System Requirements (QSR), ISO 13485, ISO 14971.
• Orthopedic or spine experience preferred.
• RAC certification preferred.
• Must have 510(k) submission experience.
• Must be detail oriented and possess strong technical writing skills.
• Must have the ability to think critically and strategically.
• Must possess strong interpersonal communication, teamwork and organizational skills.

Education and Experience

• Minimum 4 Year / Bachelor’s Degree in a STEM Field.
• 5+ 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. $110,000 to $145,000 Full-Time Annual Salary