Sr. Regulatory Affairs Specialist Job at Spinal Elements, Carlsbad, CA

M0NBb0dOeU9XUjJmdXpqVldhM0xJVzBWeEE9PQ==
  • Spinal Elements
  • Carlsbad, CA

Job Description

Sr. Regulatory Affairs Specialist

About Spinal Elements

Spinal 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 procedures, Spinal Elements combines leading medical device technologies, biologics, and instrumentation to create positive surgical outcomes that exceed surgeon and patient expectations. Spinal Elements has built a reputation delivering innovative and differentiated technologies that enable fundamental shifts in solutions for spine surgery. The company markets a complete portfolio of advanced spinal implant technologies. Learn more at

Meet the Team:

The Senior Regulatory Affairs Specialist is a key member of the Regulatory Affairs team and reports to the Associate Director, Regulatory Affairs. This role is responsible for ensuring compliance with applicable regulations and supporting the development and approval of medical devices. The Regulatory Affairs team at Spinal Elements plays a critical role in maintaining regulatory compliance, liaising with regulatory agencies, and providing strategic guidance on regulatory requirements. Additionally, the team works closely with cross-functional departments to support product development, submissions, and post-market surveillance activities.

About the Role:

The Senior Regulatory Specialist is responsible for the coordination and preparation of document packages for regulatory submissions for new and mature products, ensuring alignment and compliance with local, regional, and global registration requirements, as well as company policies. Reporting to the Associate Director of Regulatory Affairs, this role actively participates in Quality System compliance, leads regulatory strategy development, and provides expert guidance on compliance initiatives. The Senior Specialist plays a crucial role in direct interactions with regulatory agencies and serves as a mentor to junior regulatory professionals.

Primary Responsibilities Include:

  • Lead and oversee regulatory submission processes, ensuring successful approval and compliance.
  • Develop and implement regulatory strategies to streamline submission pathways and optimize approval timelines.
  • Manage and facilitate direct interactions with regulatory agencies on complex regulatory matters.
  • Mentor and train junior regulatory professionals, fostering expertise and regulatory knowledge within the team.
  • Serve as regulatory representative on new product development teams.
  • Provide high-level recommendations on labeling, manufacturing, marketing, and clinical protocols to maintain compliance and for new product development.
  • Actively drive continuous improvement in regulatory documentation processes and tracking systems.
  • Monitor industry changes and proactively assess regulatory impact on business operations.
  • Lead Quality System compliance efforts, supporting internal/external audits, CAPA and policy development.
  • Support and guide clinical trial application submissions, ensuring alignment with strategic objectives.

What Makes you Successful (KSA’s):

  • Strong leadership and ability to influence regulatory strategy at an organizational level.
  • Advanced expertise in regulatory submissions (510(k), PMA), UDI and compliance processes for medical devices.
  • Knowledge of international regulatory frameworks (Australia, , Europe, Mexico, Brazil).
  • Strong decision-making skills in complex regulatory matters.
  • Expertise in ISO 13485, 21 CFR 820, MDSAP, and MDR regulations.
  • Ability to analyze regulatory updates and provide proactive strategic solutions.
  • High attention to detail with the ability to manage multiple high-priority projects.
  • Proficiency in regulatory documentation systems and compliance tracking tools.
  • Experience leading audits and compliance initiatives.

What You’ll Get (Benefits & Perks)

  • A full and comprehensive benefits program including medical, dental, vision, short term and long-term disability, flexible spending accounts, and more
  • Wellness program and Employee Assistance Program (EAP)
  • Retirement savings plan (401k) with 4% company match
  • Educational reimbursement program
  • Travel Assistance Program, Pet Insurance and Legal Services
  • 10 paid company holidays and 1 floating holiday
  • 15 days PTO

Education and Experience:

Bachelor’s degree required; advanced degree preferred.

5+ years of regulatory affairs experience in the medical device industry or a closely related field.

Travel: Minimal travel required (less than 10%)

Work Authorization

US Work Authorization required

Work Environment

This job operates in an office setting.

Compensation

Pay range: $100,000 to $120,000 annual base salary.

Physical Demands

While performing the duties of this job, the employee is regularly required to stand; walk; sit; use hands to finger, handle, or feel; reach with hands and arms; and talk or hear. Specific vision abilities required by this job include close vision, color vision, and ability to adjust focus.

The employee will be required to perform duties at a computer workstation on a computer and phone. Must be able to lift up to 50 pounds to prepare specimens and surgical set for events.

Spinal Elements is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, or protected veteran status and will not be discriminated against on the basis of disability.

Job Tags

Holiday work, Temporary work, Local area, Flexible hours, Shift work,

Similar Jobs

Marriott International, Inc

Housekeeper Public Areas Job at Marriott International, Inc

 ...InformationPay: $21.22/hour, Public Areas Attendant Job Number 25093934 Job Category Housekeeping & Laundry Location The Ritz-Carlton Lake Tahoe, 13031 Ritz Carlton Highlands Court, Truckee, California, United States, 96161 VIEW ON MAP Schedule Full Time... 

MightyFly

Test Pilot Job at MightyFly

 ...across the United States and you will be a key player in the logistics of those operations. Flight testing often requires early morning...  ...work cross functionally Nice to have ~ Familiarity with aviation certification standards & processes ~ Military service background... 

Joyce Windows, Sunrooms & Baths

Earn Big on Evenings & Weekends as an Event Marketing Promoter Part/Full-Time Job at Joyce Windows, Sunrooms & Baths

 ...Earn Big on Evenings & Weekends as an Event Marketing Promoter - Part-Time & Full-Time Opportunities with Growth! Are you outgoing, energetic, and love connecting with new people? Looking for flexible hours that fit your lifestyle AND a chance to grow your career?... 

Frank Kent Cadillac

Sales Appointment Scheduler Job at Frank Kent Cadillac

 ...vehicles and services ~ Employee Discount Card Responsibilities Answer customer calls and establish follows-up with sales appointments. Respond quickly to internet, phone and live chat inquiries using email, scripts and templates. Provide customers with... 

SCA Health

Senior Market Accountant Job at SCA Health

 ...Senior Market Accountant JOB_DESCRIPTION.SHARE.HTML CAROUSEL_PARAGRAPH JOB_DESCRIPTION.SHARE.HTML ~ Birmingham, Alabama ~ Surgical Care Affiliates ~ Finance ~ Regular ~ Full-time ~1~ USD $75,000.00/Yr. ~ USD $85,000.00/Yr. ~39932 SCA Health...