Sr. Specialist, Regulatory Affairs

4 weeks ago

Carlsbad, United States Alphatec Spine Full time
Job DescriptionJob Description

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

  • Sr. Specialist, Regulatory Affairs

    3 months ago

    Carlsbad, United States Alphatec Spine Full time

    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...

  • Sr. Specialist, Regulatory Affairs

    3 months ago

    Carlsbad, United States Alphatec Spine Full time

    Job DescriptionJob DescriptionThe 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...

  • Regulatory Affairs Specialist

    4 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Job DescriptionJob DescriptionPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance.Essential Duties and Responsibilities Collaborates as a core team member on new product...

  • Regulatory Affairs Specialist

    3 months ago

    Carlsbad, United States Alphatec Spine Full time

    Job DescriptionJob DescriptionPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance.Essential Duties and Responsibilities Collaborates as a core team member on new product...

  • Regulatory Affairs Coordinator

    2 weeks ago

    Carlsbad, United States Danaher Corporation Full time

    Position Overview:The Regulatory Affairs Associate plays a crucial role in ensuring compliance with regulatory standards and facilitating the approval process for design documentation.Key Responsibilities:- Conduct regulatory assessments and develop plans for design control activities.- Ensure adherence to regulatory compliance requirements across US, EU,...

  • Lead Regulatory Affairs Consultant

    1 week ago

    Carlsbad, United States Internetwork Expert Inc Full time

    Position Overview:The Senior Regulatory Affairs Specialist will be responsible for crafting regulatory submissions for both domestic and international spinal product approvals. This role will also involve collaborating with spinal product design teams on change control processes and regulatory submissions.Key Responsibilities:1. Provide regulatory expertise...

  • Senior Regulatory Affairs Specialist

    2 months ago

    Carlsbad, United States Bolt Medical Full time

    DIRECT CANDIDATES ONLY, IF INTERESTED APPLY THROUGH JOB POST. NO DIRECT MESSAGES.RECRUITERS: DO NOT CONTACT.The Senior Regulatory Affairs Specialist is responsible for generating worldwide product approval submission activities for the company in accordance with all applicable regulations. This position plays a key role in the success of the organization's...

  • Regulatory Affairs Manager

    1 day ago

    Carlsbad, United States Meet Full time

    A growing medical device company based in North San Diego county is hiring a Regulatory Affairs Manager for their QA/RA department. The company is developing breakthrough products for the treatment of cardiac arrhythmias and will be commercializing several new products by the end of this year and early next.The RA Manager will be responsible for leading the...

  • Regulatory Affairs Manager

    6 hours ago

    Carlsbad, United States Meet Full time

    A growing medical device company based in North San Diego county is hiring a Regulatory Affairs Manager for their QA/RA department. The company is developing breakthrough products for the treatment of cardiac arrhythmias and will be commercializing several new products by the end of this year and early next.The RA Manager will be responsible for leading the...

  • Lead Regulatory Affairs Consultant

    1 week ago

    Carlsbad, United States Internetwork Expert Inc Full time

    Position Overview:The role involves the formulation of regulatory submissions for both domestic and international spinal product approvals. Collaborate with spinal product design teams on change management and regulatory documentation.Key Responsibilities:Provide guidance on domestic and international regulatory strategies for products, including spinal...

  • Regulatory Affairs Assistant

    2 weeks ago

    Carlsbad, United States Ultimate Staffing Full time

    Local medical device manufacturing company seeking administrative support in their Regulatory Affairs department. Submit change notification Update Technical Documentation for address and manufacturing changes Work cross functionally to draw up details of manufacturing and address changesTrack and follow-up communication with all international Distributors...

  • Regulatory Affairs Assistant

    2 weeks ago

    Carlsbad, United States Ultimate Staffing Full time

    Local medical device manufacturing company seeking administrative support in their Regulatory Affairs department. Submit change notification Update Technical Documentation for address and manufacturing changes Work cross functionally to draw up details of manufacturing and address changesTrack and follow-up communication with all international Distributors...

  • Lead Regulatory Affairs Strategist

    7 days ago

    Carlsbad, United States Thermo Fisher Scientific Full time

    Thermo Fisher Scientific is seeking a seasoned professional in Regulatory Affairs to become part of the Bio-Sciences Division team. This position offers the flexibility of remote work. Key Responsibilities:Formulate and execute comprehensive global regulatory strategies.Oversee the development of FDA pre-submission packages and facilitate meetings.Draft and...

  • Regulatory Compliance Specialist

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Position OverviewThe 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 ResponsibilitiesActively participates as a key member...

  • Vice President of Regulatory Affairs

    2 weeks ago

    Carlsbad, United States Spinal Elements Full time

    About Spinal ElementsSpinal Elements is a Carlsbad, California-based medical device company focused on the design, development, and commercialization of a comprehensive portfolio of systems, products, and technologies for spine surgery procedures. A leading designer, developer, manufacturer, and marketer of innovative medical devices used in spinal surgical...

  • Strategic Regulatory Affairs and Quality Assurance Leader

    15 hours ago

    Carlsbad, United States Spinal Elements Full time

    About Spinal ElementsSpinal Elements is a leading medical device company focused on the design, development, and commercialization of innovative systems, products, and technologies for spine surgery procedures.The company combines cutting-edge medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon...

  • Senior Specialist in Regulatory Compliance

    2 weeks ago

    Carlsbad, United States Alphatec Spine Full time

    Position OverviewAs a Senior Regulatory Affairs Specialist, you will play a crucial role in the development and submission of regulatory documents for both domestic and international spinal products. Your expertise will support our spinal product design teams in navigating change control processes and regulatory submissions.Key ResponsibilitiesYour...

  • Regulatory Compliance Specialist

    2 weeks ago

    Carlsbad, California, United States Alphatec Spine Full time

    Position OverviewThe 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...

  • Sr. Manager, Clinical Affairs

    2 months ago

    Carlsbad, United States Carlsmed Full time

    Job DescriptionJob DescriptionSalary: About Carlsmed                                                                                                                             Our mission is to improve outcomes and decrease the cost of...

  • Senior Manager, Compliance Affairs

    2 weeks ago

    Carlsbad, United States Thermo Fisher Scientific Full time

    Thermo Fisher Scientific is seeking a seasoned professional in Regulatory Affairs to become a vital member of the Bio-Sciences Division team. This role offers the flexibility of remote work. Key Responsibilities:Formulate and execute comprehensive global regulatory strategies.Oversee the preparation of FDA pre-submission documentation and coordinate...