CrawlJobs Logo

Research Regulatory Compliance Specialist

childrenshospital.org Logo

Boston Children's Hospital

Location Icon

Location:
United States , Brookline

Category Icon

Job Type Icon

Contract Type:
Not provided

Salary Icon

Salary:

62212.80 - 99528.00 USD / Year

Job Description:

At Boston Children’s Hospital, the quality of our care – and our inclusive hospital working environment – lies in the diversity of our people. With patients from local communities and 160 countries around the world, we’re committed to reflecting the spectrum of their cultures, while opening doors of opportunity for our team. Here, different talents pursue common goals. Voices are heard and ideas are shared. Join us, and discover how your unique contributions can change lives. Yours included. Position Summary: The Rosamund Stone Zander and Hansjoerg Wyss Translational Neuroscience Center (TNC) is seeking a dynamic and innovative Research Regulatory Compliance Specialist to join our team. The TNC strives to improve the lives of all children with neurodevelopmental disorders by fostering timely and efficient translational research. The Specialist will assist with and oversee regulatory submissions, provide staff training and guidance and serve as a regulatory compliance expert to develop and implement policies for the Center. The specialist will collaborate with Center leadership, investigators and their research teams, and other involved institutional groups to ensure adherence to institutional, state and federal regulatory processes and policies. This position will require an on-site presence of 2-3 times per week.

Job Responsibility:

  • Provides oversight and guidance for regulatory projects within the TNC ensuring effective set-up, operations, and close-out of all assigned projects
  • Assists with submission document development (e.g. consent forms), IRB and FDA applications
  • Provides project management and study start up support for select clinical research projects
  • Ensures execution and maintenance of all regulatory reporting, documentation, and filing for assigned projects
  • Prepares and/or oversees regulatory correspondences with internal stakeholders, Sponsors, Data Safety and Monitoring Boards, FDA, sub-contracts, vendors, and other regulatory bodies as applicable
  • Delivers education to study staff on various topics including good clinical practice, research regulations and the conduct of clinical trials
  • Develops and oversees execution of audit plans and performs audit/site visits for the purpose of reviewing data/regulatory information and querying teams/sites regarding data and regulatory issues
  • Assist in the development and implementation of internal processes and policies
  • Opportunity to contribute to additional projects
  • for example, community outreach programs and career fairs
  • Performs other assignments as required

Requirements:

  • Bachelor’s Degree in a Healthcare field is preferred
  • Two years of directly related job experience
What we offer:
  • flexible schedules
  • affordable health, vision and dental insurance
  • child care and student loan subsidies
  • generous levels of time off
  • 403(b) Retirement Savings plan
  • Pension
  • Tuition and certain License and Certification Reimbursement
  • cell phone plan discounts
  • discounted rates on T-passes

Additional Information:

Job Posted:
January 06, 2026

Employment Type:
Fulltime
Work Type:
Hybrid work
Job Link Share:

Looking for more opportunities? Search for other job offers that match your skills and interests.

Briefcase Icon

Similar Jobs for Research Regulatory Compliance Specialist

Pmfc documentator - specialist 3, clinical research

Location
Location
Belgium , Berchem-Sainte-Agathe
Salary
Salary:
Not provided
https://www.randstad.com Logo
Randstad
Expiration Date
February 25, 2026
Flip Icon
Requirements
Requirements
  • Strong writing and analytical skills
  • Attention to detail
  • Connecting the dots across different sources and cross-functional inputs
  • Preferred Experience: Medical Devices
  • Post-Market Clinical Follow-Up (PMCF)
  • Familiar with Medical Device Regulation (EU) 2017/745 and MDCG 2020-6/7/8
  • Medical writing
Job Responsibility
Job Responsibility
  • Draft and maintain PMCF Plans and PMCF Evaluation Reports
  • Support in optimizing the PMCF process (SOP/templates), as part of PMS and to keep the clinical evaluation up to date
  • Review and contribute to Periodic Safety Update Reports (PSURs). Ensure alignment with PMCF findings
  • Review and contribute to Clinical Evaluation Plans (CEPs), Clinical Evaluation Reports (CERs), Summary of Safety and Clinical Performance (SSCPs) and State of the Art (SoA) Protocol and Report. Ensure alignment with PMCF findings
  • Assist in data analysis and interpretation to assess product safety and performance
  • Contribute to PMCF Evaluation Reports, summarizing findings and clinical relevance
  • Maintain documentation for audits, inspections and regulatory submissions. Prepare, assist and attend where relevant
  • Collaborate to address feedback from Notified Bodies and Competent Authorities
  • Work closely with in Clinical Research (incl. other J&J MedTech Operating Companies) and with Scientific Operations, Regulatory Affairs, Medical Affairs, Post-Market Surveillance and other departments as appropriate
  • Support training and awareness initiatives related to PMCF to optimize collaboration
  • Fulltime
Read More
Arrow Right

Regulatory Affairs Specialist

Hemostasis, LLC designs, develops, manufactures, and markets advanced hemostat, ...
Location
Location
United States , Saint Paul
Salary
Salary:
Not provided
hemostasisllc.com Logo
Hemostasis Corp
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Regulatory Affairs and Services
  • Excellent written and oral communication skills
  • Demonstrate proactive and strategic thinking and be able to handle change and ambiguity
Job Responsibility
Job Responsibility
  • Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, and clarification/follow-up of submissions under review
  • Provide technical review of data or reports that will be incorporated into regulatory submissions
  • Analyze validation test data to determine whether systems or processes have met validation criteria
  • Study product characteristics or customer requirements and confer with management to determine validation objectives and standards
  • Identify deviations from established product or process standards and provide recommendations for resolving deviations
  • Develop validation master plans, process flow diagrams, test cases, and standard operating procedures
  • Create, populate and maintain the database for tracking validation activities, test results and validation systems
  • Prepare, maintain, and review validation and compliance documentation such as engineering change notices, schematics, and technical files to obtain and sustain product approval
  • Conduct audits of validation or performance qualification processes to ensure compliance with internal or regulatory requirements
  • Prepare additional information or responses as requested by regulatory agencies
What we offer
What we offer
  • 401K
  • Dental
  • Life
  • Medical
  • Disability
  • Competitive salary and benefits package including health, life, retirement and related benefits
  • Fulltime
Read More
Arrow Right

Non-Pharma Global Regulatory Affairs Specialist

The Global Regulatory Non-Pharma Specialist manages regulatory documentation and...
Location
Location
Italy , Bologna
Salary
Salary:
Not provided
it.alfasigma.com Logo
Alfasigma
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • At least 5 years’ experience in Regulatory Affairs preferably within the food supplements, medical devices, and cosmetics sectors
  • Exposure to regulatory operations or documentation in EU and/or RoW markets or similar experiences is preferred
  • Advance degree in Life Sciences, Pharmacy, Chemistry, or a related field
  • Relevant certifications in Regulatory Affairs are considered a plus
  • Good knowledge of EU regulations for medical devices (MDR, MDD) and relevant legislation for food supplements and cosmetics
  • Strong attention to detail, time management and organizational skills
  • Willingness to learn and ability to work effectively in a team-based environment
  • Strong communication and interpersonal skills
  • Proficiency in Microsoft Office Suite and familiarity with document management systems
  • Fluent in English, both written and spoken
Job Responsibility
Job Responsibility
  • Contributing in a cross-functional team to provide the necessary regulatory input for the development of new projects
  • Support regulatory strategies by providing impact assessments
  • Collaborate actively with the Research & Development team to integrate regulatory requirements during the design and development of assigned products
  • Prepare, organize and submit regulatory documentation for submission and maintenance of dossiers for the projects assigned
  • Coordinate with local affiliates and global stakeholders to ensure submissions are aligned with timelines and business priorities
  • Manage multiple tasks in a fast-paced environment while keeping on task and to the company’s quality standards
  • Contribute to the preparation of regulatory project updates in internal meeting and governance committee providing regulatory input and flagging risks
  • Assist colleagues with administrative tasks
  • Execute defined regulatory tasks within scope and deadlines under the guidance of the Head
  • Review and validate commercial artwork, packaging, and labeling in compliance with EU Regulations, ensuring timely product launches
What we offer
What we offer
  • Competitive salary
  • Comprehensive benefits
  • Extensive opportunities for professional growth and development
Read More
Arrow Right

Study Start-Up Specialist

The Study Start-Up Specialist supports project teams by executing study start-up...
Location
Location
Germany , Mainz
Salary
Salary:
Not provided
tfscro.com Logo
TFS HealthScience
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Bachelor’s degree preferred
  • minimum 1–3 years of relevant clinical research experience
  • Good understanding of ICH/GCP, local regulatory requirements, SOPs, and corporate standards
  • Experience with investigator start-up documents and investigative sites is preferred
  • Strong communication, organizational, and cross-functional teamwork skills
  • Ability to manage multiple priorities in a fast-paced environment
  • strong computer skills
Job Responsibility
Job Responsibility
  • Execute end-to-end start-up activities for assigned studies (country/region level), including feasibility, site identification, site initiation support, and start-up progress reporting, ensuring timelines, scope, and compliance with ICH/GCP, SOPs, protocols, and regulatory requirements
  • Collect, review, approve, track, and quality-check all regulatory and investigator documents
  • prepare and manage IEC/IRB submissions, amendments, regulatory fees, and collaborate with Regulatory on Health Authority/Competent Authority notifications
  • Lead local adaptation and documentation of Informed Consent Forms
  • ensure contracts are fully executed, regulatory approvals are granted, IP release is authorized, and all conditions for site activation are fulfilled
  • Maintain complete, accurate, and timely start-up documentation in CTMS, TMF, SMF, and central repositories
  • ensure proper submission of materials to TMF
  • support SSU Lead/PM with project set-up, Greenlight activities, and site activation processes
  • Support audits and inspections
  • provide feedback on site performance
What we offer
What we offer
  • competitive compensation package
  • comprehensive benefits
  • opportunity for personal and professional growth in a rewarding environment
Read More
Arrow Right

Senior Physician, Patient Safety

Join our dynamic Patient Safety team as a Senior Physician where you'll leverage...
Location
Location
United States; Canada , Remote; Alberta
Salary
Salary:
Not provided
parexel.com Logo
Parexel
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Experience in clinical medicine (general or specialist qualifications) which is expected to be kept up to date
  • Good knowledge of drug safety and the drug development process
  • Good knowledge/understanding of medical terminology
  • Relevant experience in pharmacovigilance/ Drug Safety/ Clinical Practice
  • 3 - 5 years previous experience in pharmacovigilance and/or medical monitoring is required
  • US Board Certification/board eligibility or regional equivalent for Canada
  • Bachelor of Medicine, Bachelor of Surgery (MBBS) / Doctor of Medicine (MD)/ Medically qualified from an acknowledged Medical School
  • Completion of at least basic training in clinical medicine (residency, internship etc.)
  • Demonstrated success in technical proficiency and scientific creativity
  • Good presentation and verbal/written communication skills
Job Responsibility
Job Responsibility
  • Maintaining a good working knowledge of the Adverse event/Safety profile of assigned products, labeling documents, data handling conventions, client’s guidelines and procedures, and global drug safety regulations and guidelines
  • Maintaining an awareness of global regulatory requirements, reporting obligations and organizing workload to ensure compliance with internal and regulatory timelines for adverse event reporting
  • Performing medical review of cases not limited to (including complex and challenging cases requiring expert judgement)), clinical trial, and literature cases including combination products {drug-device}) according to client/Parexel Standard Operating Procedures (SOPs
  • as applicable) and liaising with the client, as require
  • Writing Pharmacovigilance/Marketing Authorization Holder (MAH) comment and assessing company causality
  • Review appropriateness of medical content in narrative for medical coherence
  • Assessing seriousness, listedness / expectedness of reported events
  • Providing medical inputs to case processing team
  • Raising appropriate follow-up queries for relevant information from the reporter/HCP (Health Care Professional)
  • Review and verify appropriate selection of adverse events from source documents, assign appropriate Medical Dictionary for Regulatory Activities (MedDRA) code, review narrative
What we offer
What we offer
  • Flexible approach to work that meets your personal needs
  • Work from home
  • Benefits vary by country
  • Investment in your professional and personal development
Read More
Arrow Right

BSA Specialist

This role involves ensuring compliance with the Bank Secrecy Act, Office of Fore...
Location
Location
United States , Omaha
Salary
Salary:
Not provided
https://www.roberthalf.com Logo
Robert Half
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • 2-3 years BSA Experience e.g., bachelor's degree in finance, accounting, or a related field
  • Strong understanding of BSA, USA Patriot Act, OFAC, FinCEN guidelines, and all related regulations
  • Excellent written and verbal communication skills
  • Strong investigative and problem-solving skills
  • Proficiency in MS Office (Word/Excel/PowerPoint) and banking software systems (e.g., FIS, Jack Henry, Verafin)
  • Demonstrated ability to prioritize tasks and meet deadlines
  • Capability to work independently and collaboratively in a team setting
Job Responsibility
Job Responsibility
  • Research, analyze, and review automated alerts to identify potentially suspicious AML/Countering the Financing of Terrorism (CTF) activity
  • Evaluate alerts to determine if they can be closed or escalated for further investigation, documenting findings accurately and thoroughly
  • Partner with internal teams to collect information, conduct investigations, and escalate cases when warranted
  • Prepare and file timely Suspicious Activity Reports (SARs) and Currency Transaction Reports (CTRs) as required by regulatory guidelines
  • Compare anticipated customer activity to recorded activities and identify discrepancies or unusual patterns
  • Stay up to date on BSA/AML regulations, criminal schemes, risk typologies, and investigative techniques
  • Collaborate with branch and department managers to gather and verify information pertinent to investigations
  • Maintain comprehensive records of all alert reviews and investigations in compliance with regulatory requirements
What we offer
What we offer
  • Access to top jobs
  • competitive compensation and benefits
  • free online training
  • medical, vision, dental, and life and disability insurance
  • eligibility to enroll in company 401(k) plan
  • Fulltime
Read More
Arrow Right
New

Sr Regulatory Specialist

Regulatory Policy 1. Act to provide data and analytical support for specific seg...
Location
Location
United States , Washington, DC
Salary
Salary:
84800.00 - 116600.00 USD / Year
pepco.com Logo
Pepco
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • BS or BA in a quantitative field such as Business, Economics, Finance, Accounting or Engineering, OR in lieu of bachelor's degree, 6-9 years of related business experience
  • Five or more years electric and/or gas utility experience, primarily in the regulatory, rates, accounting, financial, or strategic planning areas
Job Responsibility
Job Responsibility
  • Act to provide data and analytical support for specific segments of regulatory filings and/or audits
  • Assist with research and analysis of accounting, tax and financial issues associated with regulatory matters
  • Apply critical analytical skills in the preparation of regulatory data filing requirements for rate case proceedings
  • Assist in the drafting of witness testimony and prepare responses to discovery requests
  • Monitor regulatory hearings, proceedings and meetings
  • Under the direction of the Regulatory Compliance Manager, act as a conduit for regulatory compliance matters including all records management matters
  • Sustain adherence to the company's records and information management program
  • Enforce document control policies and deliver training
  • Act as a subject matter liaison concerning a variety of other compliance areas facing the organization
  • Monitor and coordinate activities to manage compliance performance
What we offer
What we offer
  • Annual Bonus for eligible positions: 15%
  • 401(k) match and annual company contribution
  • Medical, dental and vision insurance
  • Life and disability insurance
  • Generous paid time off options, including vacation, sick time, floating and fixed holidays, maternity leave and bonding/primary caregiver leave or parental leave
  • Employee Assistance Program and resources for mental and emotional support
  • Wellbeing programs such as tuition reimbursement, adoption and surrogacy assistance and fitness reimbursement
  • Referral bonus program
  • Fulltime
Read More
Arrow Right
New

Electrical Engineer (Nuclear)

The Electrical Engineer (Nuclear) will be responsible for designing, maintaining...
Location
Location
Italy , Pisa
Salary
Salary:
40000.00 - 60000.00 EUR / Year
danempeople.fr Logo
Danem People France
Expiration Date
Until further notice
Flip Icon
Requirements
Requirements
  • Master’s degree in Electrical Engineering, Nuclear Engineering, or a related field
  • 3-7 years in electrical engineering, preferably in nuclear, power generation, or industrial environments (entry-level positions may require internships or co-op experience)
  • PE (Professional Engineer) license, IEEE certifications, or NRC-related qualifications (Preferred)
  • Strong comprehension of power generation, distribution, and electrical system reliability
  • Proficiency in electrical design and analysis software (e.g., ETAP, SKM PowerTools, AutoCAD Electrical)
  • Knowledge of nuclear safety standards, regulatory compliance, and emergency power systems
  • Familiarity with digital and analog control systems, instrumentation, and automation in nuclear facilities
  • Strong problem-solving and analytical abilities
  • Effective communication and teamwork skills for collaboration with engineers, operators, and regulatory agencies
  • High attention to detail and a strong commitment to nuclear safety and compliance
Job Responsibility
Job Responsibility
  • Designing, maintaining, and ensuring the safe and reliable operation of electrical systems within nuclear power plants, research facilities, and other nuclear installations
  • Working with high-voltage power distribution, emergency backup systems, instrumentation and control (I&C) systems, and regulatory compliance to ensure uninterrupted and safe plant operations
  • Collaborating with multidisciplinary teams, including reactor operators, regulatory agencies, and maintenance personnel, to optimize performance and safety
  • Designing, analyzing, and optimizing electrical systems, including power distribution, transformers, switchgear, and emergency backup systems
  • Ensuring compliance with NRC (Nuclear Regulatory Commission), IEEE, ANSI, and other regulatory and safety standards
  • Maintaining and troubleshooting plant electrical systems to prevent failures and minimize downtime
  • Developing and implementing electrical safety protocols, testing procedures, and maintenance schedules
  • Working with instrumentation and control (I&C) systems for reactor monitoring, automation, and safety mechanisms
  • Supporting plant modifications, system upgrades, and retrofits to enhance efficiency and regulatory compliance
  • Conducting fault analysis, power flow studies, and protective relaying coordination for electrical systems
  • Fulltime
Read More
Arrow Right