Regulatory Compliance Specialist

2 weeks ago

Carlsbad, United States Alphatec Spine Full time
Position Overview

The Regulatory Compliance Specialist plays a pivotal role in the submission processes for both domestic and international product clearances. This position involves supporting various daily operations, including new product initiatives, change management, and post-market evaluations.

Key Responsibilities

  • Actively participates as a key member of product development teams, formulating and documenting effective regulatory strategies for new product introductions. Engages in design control processes.
  • Drafts and submits regulatory documents, including 510(k) premarket notifications to the US FDA.
  • Prepares regulatory submissions such as technical files and design dossiers for product registration in MDSAP jurisdictions, liaising with Notified Bodies as necessary regarding significant product modifications.
  • Implements internal process enhancements, evaluates data and metrics, and maintains both internal and external databases, as well as public-facing information.
  • Conducts thorough reviews of verification and validation reports and other relevant documents to ensure scientific integrity and compliance with regulatory standards.
  • Assists in the evaluation, trending, and reporting of post-market surveillance activities, including updates to the risk management (FMEA) process.
  • Reviews product labeling and marketing materials to confirm alignment with regulatory approvals.
  • Researches various sources of regulatory information, including agency websites, standards organizations, literature, and competitor data.
  • Provides support during internal and external audits.
  • Contributes to the development, maintenance, assignment, and tracking of company Standard Operating Procedures (SOPs) to ensure adherence to global regulatory standards.
  • Maintains FDA establishment listings and registrations.
  • Demonstrates a commitment to continuous learning in regulatory affairs to enhance expertise in product submissions and relevant regulatory topics, including FDA regulations and policies pertaining to medical devices.
  • Performs additional duties as assigned.

Qualifications

The qualifications outlined below represent the necessary knowledge, skills, and abilities required for this role. Reasonable accommodations may be provided to enable individuals with disabilities to fulfill essential functions.

  • A bachelor's degree is typically required, along with 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 is essential.
  • Experience in orthopedic or spine-related fields is preferred.
  • Regulatory Affairs Certification (RAC) is advantageous.
  • Attention to detail and strong technical writing capabilities are crucial.
  • Ability to think critically and strategically is necessary.
  • Excellent interpersonal communication, teamwork, and organizational skills are required.

Education and Experience

  • A Bachelor's degree in a STEM discipline is mandatory.
  • A minimum of 1-3 years of experience in an FDA-regulated environment is expected.
  • Regulatory Affairs Certificate (RAC) accredited by the Regulatory Affairs Professionals Society (RAPS) or an equivalent certification is preferred.

Alphatec Spine is dedicated to providing equal employment opportunities to all 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 applicable laws. Furthermore, Alphatec Spine will make 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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