Current jobs related to Specialist, Regulatory Affairs - Braintree - Integra LifeSciences

  • Home Health Nurse Specialist

    4 weeks ago

    Braintree, Massachusetts, United States Aveanna Healthcare Full time

    Job OverviewAveanna Healthcare is seeking a skilled and compassionate Home Health Nurse Specialist to join our team. As a key member of our care delivery team, you will be responsible for providing high-quality patient care in the comfort of their own homes.About the JobAs a Home Health Nurse Specialist with Aveanna, you will have the opportunity to work...

  • Mental Health Therapist

    2 weeks ago

    Braintree, Massachusetts, United States Optum Full time

    About the Company">Optum is a clinician-led care organization that is revolutionizing the way mental healthcare professionals work and live.We are committed to making healthcare better for everyone, and we're looking for talented individuals like you to join our team!Estimated Salary: $65,000 - $90,000 per yearJob Description:We are seeking a highly skilled...

  • Nurse Specialist

    2 weeks ago

    Braintree, Massachusetts, United States RWJBarnabas Health Full time

    Job OverviewRWJBarnabas Health is seeking a highly dedicated Registered Nurse for Monmouth Medical Center. The ideal candidate will provide nursing care in the healthcare system within the scope of practice defined by the Nurse Practice Act and regulatory standards.ResponsibilitiesThe Registered Nurse will be responsible for reporting identified safety...

  • Healthcare Reception Support Specialist

    4 days ago

    Braintree, Massachusetts, United States SportsCare Physical Therapy Full time

    Job SummarySportsCare Physical Therapy seeks an organized and detail-oriented Medical Receptionist to manage front desk operations. This role requires excellent communication and interpersonal skills, with a focus on providing exceptional patient care.Responsibilities:Patient Scheduling: Coordinate appointments, managing schedules and communicating with the...

  • Nursing Care Specialist

    4 weeks ago

    Braintree, Massachusetts, United States RWJ Barnabas Full time

    **Job Overview**RWJBarnabas Health is an equal opportunity employer seeking a skilled Registered Nurse to provide high-quality nursing care in a dynamic healthcare environment.Estimated Salary Range: $65,000 - $90,000 per year, depending on experience and qualifications.Job Description:We are looking for a compassionate and dedicated Registered Nurse to join...

  • Geriatric Nursing Care Specialist

    1 week ago

    Braintree, Massachusetts, United States RWJBarnabas Health Full time

    RWJBarnabas Health is seeking a highly dedicated Ambulatory Care RN-QA for the Geriatric Department at Monmouth Medical Center.About the OpportunityAs a leading academic health system in New Jersey, we advance innovative strategies in high-quality patient care, education, and research to address both the clinical and social determinants of health.Job...

  • Nurse Practitioner

    3 weeks ago

    Braintree, Massachusetts, United States Mass General Brigham Full time

    About the OpportunityWe are seeking a dedicated and compassionate Registered Nurse (RN) to join our team at Mass General Brigham Healthcare at Home. As a key member of our interdisciplinary care team, you will provide high-quality, specialized care to patients in their homes, focusing on rehabilitation after illness or injury, chronic disease management, and...

  • Materials Engineer

    3 months ago

    Braintree, United States ULTRA ELECTRONICS OCEAN SYSTEMS INC. Full time

    Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies.Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldwide. With our extensive portfolio of capabilities, our innovations are utilised on...

  • Quality Assurance Inspector

    2 weeks ago

    Braintree, United States ULTRA ELECTRONICS OCEAN SYSTEMS INC. Full time

    Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies.Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldwide. With our extensive portfolio of capabilities, our innovations are utilised on...

  • Supplier Quality Engineer

    4 months ago

    Braintree, United States ULTRA ELECTRONICS OCEAN SYSTEMS INC. Full time

    Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies.Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldwide. With our extensive portfolio of capabilities, our innovations are utilised on...

  • Supplier Quality Engineer

    3 weeks ago

    Braintree, United States Ultra Maritime, LLC Full time

    Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World‘s Navies.Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering multi-mission solutions that protect and empower the naval forces worldwide. With our extensive portfolio of capabilities, our innovations are utilised...

  • Manager of Production Engineering

    3 weeks ago

    Braintree, MA, United States Ultra Electronics Group Full time

    Senior Manager of Engineering Apply locations Braintree, MA, United States time type Full time posted on Posted 30+ Days Ago job requisition id REQ-8273 Unleash the Power of Multi-Mission Excellence: Safeguarding the Seas for the World's Navies. Step into a world where cutting-edge technology meets unparalleled expertise. Ultra Maritime pioneers delivering...

Specialist, Regulatory Affairs

1 month ago

Braintree, United States Integra LifeSciences Full time

Changing lives. Building Careers. Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes. The Regulatory Affairs Specialist is an intermediate level role responsible for implementing regulatory strategies for the Company with a focus on achieving compliance for all current and upcoming regulations in the US, EU, Canada and globally. The Regulatory Affairs Specialist is responsible for providing regulatory input for regulatory documentation and development or sustaining projects to ensure that regulatory requirements are met. Responsibilities include analysis and review of data, resolution of regulatory issues of moderate scope, maintenance/update of existing technical files and ensuring that new products are compliant to new requirements. To perform this job successfully, an individual must be able to perform each essential duty satisfactorily: Utilizing an intermediate base of knowledge and understanding of regulatory requirements, documentation, language, and the submission filing process to support a focused team to ensure that the product portfolio and the required regulatory documentation is optimized for the business. Provide regulatory input to cross-functional teams. Works mostly independently to evaluate regulatory issues, contribute to, and implement regulatory strategies, and revise technical documentation for existing and new regulatory submissions. Aid Supervisor in the development of US and International regulatory strategies and verification and validation activities for assigned product submissions. Author draft submissions under supervision. Ensure timeliness of regulatory submissions according to business needs. This includes ensuring prompt follow-up to the questions and requests received from regulators. Under supervision, assist with the coordination, preparation, and maintenance of FDA PMA and BLA filings such as Annual Reports, 30 Day Notices, and 180 Day Submissions in accordance with US FDA requirements. Begin to interact with Regulatory Body personnel under direct supervision. Actively assist with upcoming audits and certification reviews with all Company designated Notified Bodies. Support communication with the Company's Notified Bodies regarding regulatory issues/questions and schedule Technical Documentation/Technical File reviews. Maintain Regulatory Affairs product files (design dossiers, periodic regulatory reports) to support compliance with regulatory requirements. Review promotional and advertising material for adherence to approved product claims and regulatory compliance. Work in partnership with Product Development, Manufacturing and QA/QC to ensure overall compliance with US, Canadian, European, and International regulations. Coordinate rollouts of product changes with corporate and international regulatory teams. Coordinate Unique Device Identification system requirements and other labeling compliance of new products introduced into the market. Work with cross-functional management to review and approve rework of non-conforming product CAPA, SCAR, HHE and Field Actions. Support product risk management in accordance with FDA/ISO 14971 under supervision. Review basic Change Engineering Requests, Document Change Requests, Variances, and other Quality System Documentation that requires regulatory review and approval to ensure compliance with government regulations. Works under moderate supervision. Review labeling that requires regulatory review and approval to ensure compliance with government regulations. Problem solving: Apply company policies and procedures to resolve a variety of issues of moderate complexity; Provide solutions to a variety of problems of moderate scope and complexity. Participate in continuous improvement projects within Regulatory Affairs and throughout the organization, as assigned. Contribute to the authoring of SOPs. Perform other duties as assigned. Qualifications: The requirements listed below are representative of the knowledge, skill, and/or ability required for this position. Bachelor's degree in Science, Engineering, Regulatory Affairs, or other technically related field. Minimum of 2 years related experience in an FDA regulated industry such as Medical Devices, Biotech or Pharma (must have at least 1 year in Regulatory Affairs and the other year can be in a related field such as Product Development, Quality, Operations to contribute to total experience). Education or certification in lieu of relevant experience accepted when the requirements below are met: RA Certification (RAC) can count towards 1 year of specific RA experience Master's degree can count towards 2 years of relevant (non-RA) experience Terminal degree (Doctorate or PhD in Business, Science, or related discipline) can count towards 4 years of relevant (non-RA) experience. Experience in working effectively with cross-functional teams (e.g., manufacturing sites, new product development teams, marketing teams, quality teams). Experience with medical device, biologic or implantable products is preferred, but not required. Awareness of business strategies and tactics, including an understanding of regulatory impact. Must have proven ability to prepare and submit documents to regulatory agencies, with supervision. Ability to explain regulatory requirements and pitfalls to project teams and colleagues. Can communicate existing facts in an organized and clear manner to cross-functional teams. Must be detail oriented, well-organized, and able to work both independently and in teams. Must possess and demonstrate an understanding of FDA requirements and quality system requirements. Must have strong writing, project management and communication skills. Demonstrated skills in contributing to multiple projects simultaneously. Established skill in objective thinking. Brings proposals for solutions to identified issues. Develops plans to meet pre-defined Regulatory goals. Responsible for tasks and intermediate submission components, based on templates. Capability to interact with diplomacy and tact while maintaining appropriate assertiveness. Willingness to take ownership and accept responsibility for actions and decisions. Ability to communicate effectively in both informal and formal settings. Regulatory Affairs Certification (RAC) is a plus and can be obtained on the job.