Regulatory Affairs Specialist

6 hours ago

Great Barrington, United States Connexion Systems & Engineering, Inc. Full time
Job DescriptionJob Description

Regulatory Affairs Specialist


Have you got what it takes to succeed The following information should be read carefully by all candidates.
  • 1 Year contract assignment

Essential Duties and Responsibilities:
The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs.

  • Responsible for the preparation and compiling of document packages for regulatory submissions, audits and inspections. Participates in technical review of data or reports that will be incorporated. Manage and maintain regulatory databases and technical files.
  • Participate in internal and external audits and investigations.
  • Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
  • Manage labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
  • Provides high-level regulatory support on projects and cross functional teams. Provides technical guidance on design reviews and regulatory strategies for product approval.
  • Contribute to developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.
  • Maintains current knowledge of existing and emerging regulations, standards and laws.
  • Administrative Responsibilities include attending all meetings (staff, core team, key one-on-one, multifunctional priority setting meetings, sustaining, etc.), reviewing and responding to emails and other messaging platforms.

Qualifications (Education & Experience):

  • Bachelor's Degree (Engineering, Biomedical or related field preferred), May have Master’s Degree, May have PhD
  • 5-8 Years, Higher education may compensate for years of experience.

Required Skills:

  • Excellent communication, including verbal, technical writing, interpersonal and presentation skills.
  • Proficient with technology applications such as MS Office,
  • Experience with the creation of technical files and documentation
  • Experience working in regulated medical device industry.
  • Knowledge of ISO 13485, ISO 14971, ISO 9001, FDA and foreign regulatory requirements
  • Strong data and statistical analysis skills and ability to use data to make informed recommendations
  • High degree of attention to detail
Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.Company DescriptionConnexion Systems & Engineering is a full-service staffing firm, whose mission is to provide "best in class" staffing services to our clients and job seekers alike. We strive to achieve excellence in staffing, job placement and recruiting services, while treating our clients, employees, and candidates with the professionalism and respect they deserve.

  • Deviation Investigation Lead

    2 days ago

    Barrington, Illinois, United States Entegee Full time

    Job Title: Deviation Investigation LeadEntegee is seeking a highly skilled Deviation Investigation Lead to join our team. As a key member of our quality assurance team, you will be responsible for leading and conducting deviation investigations on our pharmaceutical manufacturing floor.Key Responsibilities:Lead deviation investigations to identify root...

  • Deviation Investigation Lead

    1 week ago

    Barrington, Illinois, United States Entegee Full time

    Job Title: Deviation Investigation LeadEntegee is seeking a highly skilled Deviation Investigation Lead to join our team. As a key member of our quality assurance team, you will be responsible for leading and conducting deviation investigations on our pharmaceutical manufacturing floor.Key Responsibilities:Lead deviation investigations to identify root...

  • Clinical Nutrition Professional

    1 month ago

    Great Barrington, Massachusetts, United States Fairview Hospital Full time

    Job SummaryWe are seeking a highly skilled Nutrition Care Specialist to join our team at Fairview Hospital. As a key member of our healthcare team, you will be responsible for providing exceptional nutritional care to our patients, conducting thorough nutrition assessments, and collaborating with other healthcare professionals to achieve the highest...

  • Clinical Nutrition Specialist

    1 month ago

    Great Barrington, Massachusetts, United States Fairview Hospital Full time

    Position Overview:At Fairview Hospital, we are seeking a dedicated Dietitian to join our team within the Operation Better Start program. This role is essential in delivering comprehensive nutritional care to our patients.Key Responsibilities:Conduct thorough nutrition assessments and develop tailored dietary plans.Collaborate with healthcare professionals to...

  • Deviation Investigation Lead

    3 weeks ago

    Barrington, United States Entegee Full time

    Job DescriptionJob DescriptionJob Summary:Responsible for leading and conducting deviation investigations on a pharmaceutical manufacturing floor, identifying root causes, and implementing corrective and preventive actions (CAPAs).Job Requirements:Extensive experience on a pharmaceutical manufacturing floor.Strong understanding of root cause analysis and...

  • Senior Portfolio Manager

    3 weeks ago

    Great Barrington, Massachusetts, United States BMO Full time

    Job SummaryBMO is seeking a highly skilled Senior Portfolio Manager to join our Wealth Management team. As a key member of our team, you will be responsible for providing high-quality sales and service to investment clients, delivering an exceptional client experience, and ensuring compliance with all regulatory requirements.Key ResponsibilitiesDevelop and...

  • Registered Nurse

    4 weeks ago

    Great Barrington, Massachusetts, United States Aveanna Healthcare Full time

    Job SummaryAveanna Healthcare is seeking a compassionate and skilled Registered Nurse (RN) to provide high-quality nursing care to patients in their homes. As a key member of our team, you will be responsible for delivering patient-centered care, collaborating with healthcare professionals, and promoting a positive patient experience.Key...

  • Audiology Specialist

    3 weeks ago

    Great Barrington, Massachusetts, United States Highspeed Staffing Full time

    Highspeed StaffingAudiologist OpportunityWe are seeking a dedicated Audiologist to join our team at a thriving facility in Great Barrington, Massachusetts. As the sole Audiologist, you will have the unique opportunity to manage the full spectrum of hearing healthcare services.Key Responsibilities:Comprehensive Care: Oversee prevention, identification,...

  • Compliance Audit Specialist

    4 weeks ago

    Great Neck, New York, United States FREEDOM CARE , LLC Full time

    Job DescriptionJob Title: Compliance Audit SpecialistJob Summary:We are seeking a highly skilled Compliance Audit Specialist to join our team at FreedomCare, LLC. As a Compliance Audit Specialist, you will play a critical role in ensuring the integrity of our operations and maintaining regulatory compliance.Key Responsibilities:Perform audits on cases to...

  • Batch Record Review Specialist

    2 days ago

    Barrington, Illinois, United States Entegee Full time

    Job Title: Batch Record ReviewEntegee is seeking an experienced QA Batch Record Review Consultant to ensure compliance and quality in pharmaceutical production.Key Responsibilities:Conduct thorough reviews of batch records to ensure compliance with regulatory requirementsIdentify and document discrepancies, and work with cross-functional teams to resolve...

  • Financial Reporting Specialist

    1 month ago

    Great Neck, New York, United States Rosen And Glaser Cpas Pc Full time

    Opportunity for a Financial Reporting SpecialistWe are looking for a committed Financial Reporting Specialist to enhance our financial team. This position is ideal for individuals who excel in managing financial data and ensuring the precision of financial documentation.Key Responsibilities:Prepare and assess accounting documentation, financial statements,...

  • Industrial Hygiene Specialist

    4 weeks ago

    Great Neck, New York, United States Northwell Health Full time

    Job SummaryWe are seeking a highly skilled Industrial Hygiene Specialist to join our team at Northwell Health. The successful candidate will be responsible for developing and implementing programs, policies, and procedures associated with the recognition, measurement, evaluation, and control of industrial health hazards.Key ResponsibilitiesProgram...

  • Cardiac Imaging Specialist

    3 weeks ago

    Great Falls, Montana, United States TotalMed Staffing Full time

    About this RoleAs a skilled Cardiac Imaging Specialist, you will be responsible for performing echocardiograms using advanced ultrasound equipment. Your primary goal will be to ensure accurate imaging and timely results. You will work collaboratively with the diagnostic team to maintain an efficient workflow and provide exceptional patient care.Key...

  • Pediatric Speech Therapist PD

    6 days ago

    Barrington, United States Virtua Health Full time

    At Virtua Health, we exist for one reason - to better serve you. That means being here for you in all the moments that matter, striving each day to connect you to the care you need. Whether that's wellness and prevention, experienced specialists, life-changing care, or something in-between - we are your partner in health devoted to building a healthier...

  • Pediatric Speech Therapist PD

    4 days ago

    Barrington, United States Virtua Health Full time

    At Virtua Health, we exist for one reason - to better serve you. That means being here for you in all the moments that matter, striving each day to connect you to the care you need. Whether thats wellness and prevention, experienced specialists, life-changing care, or something in-between - we are your partner in health devoted to building a healthier...

  • Speech Lang Pathologist PD

    3 months ago

    Barrington, United States Virtua, Inc. Full time

    Position Responsibilities Demonstrates comprehensive evaluation skills and interventions. This includes evaluating the effectiveness of interventions and modification of plan of care as appropriate. Therapist will meet IEP mandates per student. Maintains and completes all student documentation, records and reports ensuring they are educationally based,...

  • Clinical Education Specialist

    1 month ago

    Great Neck, New York, United States Northwell Health Full time

    Job SummaryWe are seeking a highly skilled Clinical Education Specialist to join our team at Northwell Health. This is a critical role that requires a strong background in emergency medical services and education.Key ResponsibilitiesProgram Operations: Assist in planning, organizing, and managing the Emergency Medical Institute program operations, ensuring...

  • Manager of Medical Staff Services Credentialing

    4 days ago

    Barrington, United States Advocate Aurora Health Full time

    HYBRID ROLEDESIRED CANDIDATE WILL NEED TO RESIDE IN ILLINOIS or SOUTHERN WISCONSINQuarterly travel to: Lake Geneva, Racine, Burlington, Kenosha and Mt Pleasant areasThere is a lot happening at Advocate Health!Yes, we are growing and are looking for great leaders like you to join us on our journey to better health outcomes for our patients.Consider leading...

  • Quality Assurance Specialist

    4 weeks ago

    Great Neck, New York, United States Gpac Full time

    Job DescriptionCompany OverviewGpac is a leading search firm specializing in placing quality professionals within multiple industries across the United States since 1990. We are committed to delivering the right solutions at the right time.Job SummaryWe are seeking a proactive QA/QC Specialist passionate about food safety and quality to join our team. This...

  • Physical Therapist PD

    2 weeks ago

    Barrington, United States Virtua Health Full time

    At Virtua Health, we exist for one reason - to better serve you. That means being here for you in all the moments that matter, striving each day to connect you to the care you need. Whether that's wellness and prevention, experienced specialists, life-changing care, or something in-between - we are your partner in health devoted to building a healthier...