Specialist, Regulatory Compliance

Hunter Engineering Company

$80K — $95K *
Pharmaceuticals & Biotech
5 - 7 years of experience
Job Overview by Ladders

Qualifications

  • Bachelor's degree in Engineering, Engineering Technology, Regulatory Compliance, Business Administration, or related discipline.
  • 5+ years of experience in product compliance, certification, product safety, regulatory affairs, or quality engineering.
  • Experience managing various certifications like CE, UL, FCC, FDA/CDRH, and others.
  • Experience collaborating with regulatory bodies and certification agencies.
  • Familiarity with audit processes and factory inspections for product certifications.
  • Strong communication skills for cross-functional teamwork and external engagements.
  • Ability to interpret complex regulatory requirements effectively.

Responsibilities

  • Develop and execute strategies for global product compliance and market access.
  • Define regulatory requirements and create certification roadmaps for new products.
  • Embed compliance practices throughout product planning and design reviews.
  • Manage all aspects of certification testing and approvals.
  • Coordinate communications with regulatory agencies and certification bodies.
  • Oversee compliance for released products, including updates due to regulatory changes.
  • Maintain detailed compliance documentation and records.

Benefits

  • Industry-Leading Healthcare Coverage
  • Profit-Sharing Plan with Safe Harbor Contribution
  • Generous Paid Time Off & Holidays
  • Paid Parental Leave
  • Tuition Reimbursement Program
  • Free Onsite Fitness & Recreation Center
Full Job Description
As a Specialist, Regulatory Compliance, you will support Hunter's product compliance, regulatory approvals, certification programs, risk management activities, and compliance testing efforts. You will work cross-functionally with Engineering, Quality, Manufacturing, and external regulatory entities to ensure products meet applicable domestic and international regulatory standards.

What You'll Do:
  • Develop and execute global product compliance, certification, and market access strategies.
  • Define regulatory requirements and certification roadmaps for new product programs
  • Embed compliance-by-design practices into product planning, design reviews, risk assessments, verification, validation, and launch decisions
  • Manage certification testing, submissions, approvals, renewals, listings, audits, and factory inspections.
  • Coordinate work and communication with regulatory agencies, certification bodies, notified bodies, consultants, and test laboratories
  • Own sustained compliance for released products; including regulatory changes, engineering changes, supplier changes, and component obsolescence.
  • Maintain technical files, declarations, certificates, test reports, product reports, labels, manuals, and other compliance records.
  • Lead audit readiness, responses to findings, and regulatory corrective actions.
  • Coordinate product certification activities with ETL, UL, international safety and compliance organizations, and foreign regulatory and certification agencies.
  • Monitor emerging global requirements and provide leadership with clear visibility to mitigate compliance risks, schedules, investment needs, and market impacts.
  • Additional duties as assigned

What You'll Bring:
  • Bachelor's degree in Engineering, Engineering Technology, Regulatory Compliance, Business Administration, or related discipline.
  • 5+ years of progressively responsible experience in product compliance, certification, product safety, regulatory affairs, quality engineering, or a related field.
  • Experience managing several relevant certifications or approvals, i.e. CE, UL, ETL, FCC, FDA/CDRH, laser compliance, ALI, CSA, EAC/EAEU, or other international requirements.
  • Experience working with certification bodies, regulatory agencies, consultants, and independent laboratories.
  • Experience leading or supporting product certification audits, surveillance activities, or factory inspections.
  • Strong product management, technical documentation, cross-functional leadership, and communication skills with internal teams and external organizations are essential.
  • The ability to interpret complex requirements and translate them into practical products and process actions.
  • Knowledge of ISO 9001, ISO/IEC 17025, IEC standards, machinery regulations, environmental substance requirements, or functional safety standards.
  • Professional certifications preferred

What We Offer:
  • Industry-Leading Healthcare Coverage
  • Profit-Sharing Plan with Safe Harbor Contribution
  • Generous Paid Time Off & Holidays
  • Paid Parental Leave
  • Tuition Reimbursement Program
  • Free Onsite Fitness & Recreation Center

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