Regulatory Compliance Specialist

2 weeks ago


Carlsbad California, United States Alphatec Spine Full time
Position Overview

The primary focus of this role is to oversee the preparation and submission of regulatory documentation for both domestic and international product approvals. This position also involves supporting ongoing operations related to product innovation, modifications, and market surveillance.

Key Responsibilities

- Collaborate as an integral member of product development teams, defining and documenting the regulatory approach for new product initiatives.
- Engage in design control processes to ensure compliance with regulatory standards.
- Prepare regulatory submissions, including 510(k) premarket notifications for the US FDA.
- Develop technical files and design dossiers for product registration in MDSAP countries, and liaise with Notified Bodies for significant product changes.
- Drive internal process enhancements, evaluate data and metrics, and maintain both internal and external databases, along with public-facing information.
- Conduct thorough reviews of verification and validation reports to ensure scientific validity and compliance with regulatory mandates.
- Assist in post-market surveillance assessments, including trend analysis and reporting, and contribute to updates in the risk management process (FMEA).
- Review product labeling and marketing materials to ensure alignment with regulatory approvals.
- Research regulatory information from various sources, including agency websites and industry literature.
- Provide support during internal and external audits.
- Aid in the development, maintenance, and tracking of company Standard Operating Procedures (SOPs) to ensure adherence to global regulatory standards.
- Maintain FDA establishment listings and registrations.

Qualifications

The ideal candidate will possess:
- A bachelor's degree and a minimum of 3 years of experience in the medical device sector.
- In-depth knowledge of FDA Quality System Requirements (QSR), ISO 13485, and ISO 14971.
- Preferred experience in orthopedic or spine-related fields.
- Regulatory Affairs Certification (RAC) is a plus.
- Strong attention to detail and exceptional technical writing abilities.
- Critical and strategic thinking skills.
- Excellent interpersonal communication, teamwork, and organizational capabilities.

Education and Experience

- A Bachelor's degree in a STEM discipline is required.
- At least 1-3 years of experience in an FDA-regulated environment.
- Regulatory Affairs Certificate (RAC) from the Regulatory Affairs Professionals Society (RAPS) or equivalent is preferred.

Equal Opportunity Statement

Alphatec Spine is dedicated to providing equal employment opportunities to all employees and applicants, irrespective of race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status as per applicable laws. We are committed to making reasonable accommodations necessary to comply with disability discrimination laws.

Compensation

Alphatec Spine, Inc. adheres to state and federal wage and hour regulations, with compensation dependent on the candidate's qualifications, education, skill set, years of experience, and internal equity. The salary range for this position is $92,600 to $112,700 annually.

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