Talent.com
Regulatory Affairs Specialist
Regulatory Affairs SpecialistBeth Israel Lahey Health • Burlington, MA, US
serp_jobs.error_messages.no_longer_accepting
Regulatory Affairs Specialist

Regulatory Affairs Specialist

Beth Israel Lahey Health • Burlington, MA, US
job_description.job_card.1_day_ago
serp_jobs.job_preview.job_type
  • serp_jobs.job_card.full_time
job_description.job_card.job_description

Regulatory Affairs Specialist

When you join the growing BILH team, you're not just taking a job, you're making a difference in people's lives.

The Regulatory Affairs Specialist supports the activities of the Regulatory Affairs Department in ensuring compliance with accreditation, licensing, and regulatory requirements, including those from Joint Commission (JC), CMS and MA Department of Public Health. This position assists with survey readiness, documentation management, performance tracking, and communication related to quality, safety, and compliance initiatives across the organization. The Regulatory Affairs Specialist works under the direction of the Director of Regulatory Affairs, collaborating closely with clinical departments, quality and patient safety teams, and administrative leaders to maintain a continuous state of regulatory readiness.

Essential Responsibilities, but not limited to :

  • Acts as a coordinator to hospital-wide accreditation readiness committee and a working subgroup contributor.
  • Assist in coordinating hospital-wide accreditation and licensing activities, including preparation for regulatory surveys and inspections.
  • Maintain documentation related to accreditation readiness, compliance action plans, and performance metrics.
  • Support the development and organization of materials for internal audits and mock surveys; track follow-up actions and ensure timely completion.
  • Communicate updates on regulatory requirements and standards to key stakeholders.
  • Participate in the preparation of educational resources, presentations, and communication materials regarding regulatory or accreditation updates.
  • Assist in creating and maintaining content for internal portals or intranet pages related to regulatory compliance.
  • Provide administrative and logistical support for committee meetings, audits, and regulatory readiness projects.
  • Conduct basic observations, audits, and chart reviews under the guidance of Regulatory Affairs Director to identify areas for improvement.
  • Coordinate follow-up on corrective action plans and monitor progress toward compliance goals.
  • Establish and maintain collaborative relationships with colleagues across departments and with clinical affiliates as needed.
  • Provide education regarding regulatory requirements; serve as a point of contact for inquiries regarding regulatory compliance.

Required Qualifications :

  • Bachelor's degree in clinical / healthcare management or related field; Master's degree preferred.
  • 3-5 years of related work experience.
  • Proficiency in Microsoft Office (Word, Excel, PowerPoint, Outlook) and database management.
  • Strong organizational skills, attention to detail, and ability to coordinate multiple priorities.
  • Preferred Qualifications :

  • Experience supporting Joint Commission, CMS, or state licensing surveys preferred.
  • Knowledge of healthcare quality improvement or patient safety initiatives.
  • Familiarity with Lean or PDSA methodologies.
  • Competencies :

  • Problem Solving : Gathers and analyzes information to identify issues and propose practical solutions.
  • Communication : Communicates effectively in both written and verbal form; able to summarize regulatory information for varied audiences.
  • Teamwork : Works collaboratively across departments to support compliance initiatives and survey readiness.
  • Customer Service : Demonstrates professionalism and responsiveness in interactions with staff, patients, and external surveyors.
  • Knowledge : Understands basic regulatory and accreditation concepts; applies this knowledge under supervision.
  • Provide education regarding regulatory requirements; serve as a point of contact for inquiries regarding regulatory compliance.
  • Pay Range : $40.87 USD - $62.50 USD

    The pay range listed for this position is the annual base salary range the organization reasonably and in good faith expects to pay for this position at this time. Actual compensation is determined based on several factors, that may include seniority, education, training, relevant experience, relevant certifications, geography of work location, job responsibilities, or other applicable factors permissible by law.

    As a health care organization, we have a responsibility to do everything in our power to care for and protect our patients, our colleagues and our communities. Beth Israel Lahey Health requires that all staff be vaccinated against influenza (flu) as a condition of employment.

    More than 35,000 people working together. Nurses, doctors, technicians, therapists, researchers, teachers and more, making a difference in patients' lives. Your skill and compassion can make us even stronger.

    Equal Opportunity Employer / Veterans / Disabled

    serp_jobs.job_alerts.create_a_job

    Regulatory Specialist • Burlington, MA, US

    Job_description.internal_linking.related_jobs
    Director, Contact Dermatitis Program

    Director, Contact Dermatitis Program

    Beth Israel Lahey Health • Burlington, MA, United States
    serp_jobs.job_card.full_time
    Lead our Contact Dermatitis Program!.Lahey Hospital and Medical Center (part of Beth Israel Lahey Health) is seeking a Director to lead and grow our Contact Dermatitis Program.Lead and grow clinica...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Specialist, Academic Development

    Specialist, Academic Development

    Relativity • Manchester, NH, United States
    serp_jobs.job_card.full_time
    The Specialist, Academic Development focuses on researching, approaching, and signing law schools to Relativity's Academic program. This role requires ingenuity and grit to build relationships with ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality Systems Specialist

    Quality Systems Specialist

    DEKA Research and Development • Manchester, NH, United States
    serp_jobs.job_card.full_time
    As a Quality Systems Specialist, you will contribute in the following areas : .Conduct Receipt and processing of field returned product. Review and approve quality records to ensure accuracy, complete...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    AI Trainer -Remote Editorial Specialist

    AI Trainer -Remote Editorial Specialist

    Outlier • Manchester, NH, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Analyst I, Rates and Regulatory Affairs

    Analyst I, Rates and Regulatory Affairs

    Liberty Utilities Co • Londonderry, NH, United States
    serp_jobs.job_card.full_time
    Analyst I, Rates and Regulatory Affairs.Algonquin Power & Utilities Corp.AQN), parent company of Liberty, is a diversified international generation, transmission, and distribution utility.AQN is co...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Associate Director, Oncology GRA

    Associate Director, Oncology GRA

    Women In Bio • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Be accountable to the Global Regulatory Lead (GRL) and Global Regulatory Therapeutic Area (TA) Head for the development of appropriate regional regulatory strategies and their delivery according to...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Conservation Regulatory Aide (PDF)

    Conservation Regulatory Aide (PDF)

    Town of Lexington • Lexington, MA, United States
    serp_jobs.job_card.part_time
    We are currently accepting applications for the Per Diem position : .Conservation Regulatory Aide (Part-time / Flexible hours). Department of Land Use, Housing & Development.The REQUIRED Town of Lexingt...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, CMC Regulatory Affairs — Strategy

    Associate Director, CMC Regulatory Affairs — Strategy

    Alkermes, Inc. • Waltham, MA, United States
    serp_jobs.job_card.full_time
    A leading biopharmaceutical company is seeking an experienced Associate Director for Regulatory Affairs CMC to provide strategic regulatory direction and manage various CMC activities related to a ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Travel Certified Surgical Technologist (CST) in Lancaster, NH

    Travel Certified Surgical Technologist (CST) in Lancaster, NH

    AlliedTravelCareers • Manchester, New Hampshire, US
    serp_jobs.job_card.full_time +1
    AlliedTravelCareers is working with Lancesoft Inc.CST in Lancaster, New Hampshire, 03584!.We are currently seeking qualified candidates for Certified Surgical Tech. Shift 5x8 Days, 08 : 00 : 00-16 : 00 : 00...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Biocompatibility & Toxicology Senior Scientist

    Biocompatibility & Toxicology Senior Scientist

    DEKA Research and Development • Manchester, NH, United States
    serp_jobs.job_card.full_time
    DEKA Research & Development has an immediate opening for a Biocompatibility & Toxicology Senior Scientist to join our team focused on medical device and combination product development.The individu...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Associate Director, CMC Regulatory Affairs

    Associate Director, CMC Regulatory Affairs

    Alkermes, Inc. • Waltham, MA, United States
    serp_jobs.job_card.full_time
    Regulatory Affairs Chemistry, Manufacturing, and Controls (CMC), plays a critical role in supporting a diverse portfolio of small molecule development programs and marketed products across multiple...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Quality and Regulatory Service Associate

    Quality and Regulatory Service Associate

    Nesco Resource • Tewksbury, MA, US
    serp_jobs.job_card.full_time
    Quality And Regulatory Services Support.Location : Onsite - Tewksbury, MA.Possibility for hybrid (3 days per week in office) for exceptional candidate once training period is complete.No relocation ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Manager, Regulatory Affairs (Biosimilars)

    Senior Manager, Regulatory Affairs (Biosimilars)

    Fresenius Kabi USA, LLC • Manchester, NH, United States
    serp_jobs.job_card.full_time
    The Senior Manager, Regulatory Affairs delivers Regulatory Affairs and compliance guidance and strategic input as a subject matter expert in Biosimilar Development and Life Cycle Management to find...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Oncology Global Regulatory Affairs Associate Director

    Oncology Global Regulatory Affairs Associate Director

    Women In Bio • Waltham, MA, United States
    serp_jobs.job_card.full_time
    A global biopharma company is seeking a regulatory professional in Waltham, MA, to lead regional regulatory strategies and collaborate with commercial teams. The ideal candidate has a Bachelor's deg...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_hours • serp_jobs.job_card.promoted • serp_jobs.job_card.new
    Travel Certified Surgical Technologist (CST) - $1,925 per week in New London, NH

    Travel Certified Surgical Technologist (CST) - $1,925 per week in New London, NH

    AlliedTravelCareers • Manchester, New Hampshire, US
    serp_jobs.job_card.full_time
    AlliedTravelCareers is working with TRS Healthcare to find a qualified CST in New London, New Hampshire, 03257!.TRS Healthcare is seeking an experienced OR - Operating Room Certified Surgical Tech ...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Remote Editorial Specialist

    Remote Editorial Specialist

    Outlier • Lowell, MA, United States
    serp_jobs.filters.remote
    serp_jobs.job_card.full_time
    Earn up to $15 / hour + performance bonuses.Outlier, a platform owned and operated by Scale AI, is looking for.If you're passionate about improving models and excited by the future of AI, this is you...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days • serp_jobs.job_card.promoted
    Senior Director, Regulatory CMC

    Senior Director, Regulatory CMC

    Apellis Pharmaceuticals, Inc. • Waltham, MA, United States
    serp_jobs.job_card.full_time
    The Senior Director, Regulatory CMC will lead and evolve Apellis's global Chemistry, Manufacturing, and Controls (CMC) strategies to support the company's innovative therapeutic pipeline and market...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_30 • serp_jobs.job_card.promoted
    Regulatory Affairs Professional

    Regulatory Affairs Professional

    804 Technology • Newton, Massachusetts, US
    serp_jobs.job_card.full_time
    serp_jobs.filters_job_card.quick_apply
    As a Regulatory Affairs Specialist Consultant, you will be responsible for : .Formulate and execute activities associated with regulatory submissions of a novel robotic medical device in the US marke...serp_jobs.internal_linking.show_more
    serp_jobs.last_updated.last_updated_variable_days