Sr. Regulatory Affairs Specialist

2 months ago

chelmsford, United States Planet Pharma Full time

Position Summary

The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists as part of the role.

Principal Responsibilities

• Conduct appropriate research using standards, guidance documents, previous assessments and other resources to develop strong regulatory assessments for the US, EU and Canada for new and modified products.

• Assume full responsibility for project submissions for 510(k) premarket notifications, EU MDD Technical File/MDR Technical Documentation, and Canadian license submission/amendments.

• Communicate with Commercial RA to ensure timely notification of changes as appropriate. Partner with Commercial RA to support registration of product in foreign markets.

• Work with Quality, Operations, Engineering, and other internal groups to investigate and recommend solutions to address potential regulatory issues and impacts.

• Interact and negotiate with regulatory authorities during the development (i.e. Q-Sub, change notifications, etc.) and submission review.

• Support regulatory agency and/or notified body audits by as needed.

• Participate in and ensure compliance with design controls and review design documentation to confirm regulatory requirements are met.

• Participate in development and approval of risk activities as well as other deliverables as related to projects.

• Provide regulatory review for reporting activities required by EU MDR (i.e. post-market surveillance, reporting, etc.).

• Review and approve all Labeling (product, advertising and promotional) and ensure claims are substantiated.

• Assist in regulatory due diligence process as needed.

• Proactively drive RA project deliverables by collaborating cross-functionally and engaging with cross-business unit team members as needed.

• Monitor impact of changing evolving global regulations on submissions, practices and procedures and communicate to internal stakeholders.

• Brings Regulatory Affairs questions/issues to the attention of RA management.

• Comply with Code of Ethics, all Company policies, rules, and procedures.


Education / Experience Requirements

• Bachelor’s degree in a science or engineering field, or equivalent work experience.

• 5+ years of Medical Device Regulatory Affairs experience, domestic and international. 3 years of experience with Class I, II or III medical devices.

• Proven history of successful domestic and/or international submissions.


Specialized Skills / Other Requirements

• Strong analytical and critical thinking skills.

• Strong verbal and writing communication skills.

• Ability to manage and prioritize multiple projects to meet deadlines that align with the BU’s objectives.

• Proven track record of working as a team player to overcome obstacles and complete tasks through collaboration.

• Proficiency in MS Office software programs

• RAC certification is a plus.

  • Sr. Regulatory Affairs Specialist

    1 month ago

    Chelmsford, United States Planet Pharma Full time

    Position SummaryThe Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists...

  • Sr. Regulatory Affairs Specialist

    2 months ago

    Chelmsford, United States Planet Pharma Full time

    Position SummaryThe Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents, investigations, product development planning and regulatory agency interaction. The SRA will assist in mentoring and development of Regulatory Specialists...

  • Regulatory Affairs Specialist

    1 month ago

    Chelmsford, United States Planet Pharma Full time

    Immediate Need for Regulatory Affairs Specialist with a medical device company in Chelmsford, MA for a 12 month contract. 3 days a week on site and 2 days remote. The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents,...

  • Regulatory Affairs Specialist

    2 months ago

    chelmsford, United States Planet Pharma Full time

    Immediate Need for Regulatory Affairs Specialist with a medical device company in Chelmsford, MA for a 12 month contract. 3 days a week on site and 2 days remote. The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents,...

  • Regulatory Affairs Specialist

    2 months ago

    Chelmsford, United States Planet Pharma Full time

    Immediate Need for Regulatory Affairs Specialist with a medical device company in Chelmsford, MA for a 12 month contract. 3 days a week on site and 2 days remote. The Sr. Regulatory Affairs Specialist (SRA) will develop US, EU, and Canada strategies, assessments and submissions for complex projects and review issues related to regulatory documents,...

  • Regulatory Affairs Coordinator

    2 weeks ago

    Chelmsford, United States ZOLL Medical Full time

    Circulation, ZOLLMED.com At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory...

  • Regulatory Affairs Coordinator

    3 weeks ago

    Chelmsford, United States ZOLL Medical Full time

    Circulation, ZOLLMED.com At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory...

  • Medical Device Regulatory Specialist

    2 days ago

    Chelmsford, Massachusetts, United States Planet Pharma Full time

    About the RoleWe are looking for a Senior Regulatory Affairs Specialist to assist in developing and implementing regulatory strategies for our medical device products. The successful candidate will work closely with cross-functional teams to ensure compliance with regulatory requirements.This is an excellent opportunity for experienced professionals to take...

  • Post Market Surveillance Senior Specialist

    2 weeks ago

    Chelmsford, United States Zoll Medical Corporation Full time

    Resuscitation At ZOLL, we're passionate about improving patient outcomes and helping save lives. We provide innovative technologies that make a meaningful difference in people's lives. Our medical devices, software and related services are used worldwide to diagnose and treat patients suffering from serious cardiopulmonary and respiratory conditions. The ACT...

  • Supply Chain Logistics Associate

    5 days ago

    Chelmsford, Massachusetts, United States A-Line Staffing Solutions Full time

    Job Summary:A-Line Staffing Solutions is seeking an experienced Inventory Specialist to join our team at a Department of Veteran Affairs Mail Order Pharmacy. As an Inventory Specialist, you will be responsible for managing and maintaining pharmaceutical inventory, operating advanced pharmacy automation equipment, and handling and organizing medications.About...

  • Pharmacy Operations Coordinator

    5 days ago

    Chelmsford, Massachusetts, United States A-Line Staffing Solutions Full time

    Job Overview:A-Line Staffing Solutions is seeking an experienced Inventory Specialist to join our team at a Department of Veteran Affairs Mail Order Pharmacy. As an Inventory Specialist, you will play a crucial role in ensuring the smooth operation of our pharmacy by managing and maintaining pharmaceutical inventory.Key Responsibilities:Manage and maintain...

  • Pharmaceutical Services Specialist

    5 days ago

    Chelmsford, Massachusetts, United States Ansible Government Solutions Full time

    Job Summary:We're seeking a skilled Pharmaceutical Services Specialist to join our team at Ansible Government Solutions. As a key member of our team, you'll play a crucial role in supporting the U.S. Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) facility. Your primary responsibility will be to prepare prescriptions and...

  • Inventory Specialist

    2 weeks ago

    Chelmsford, United States A-Line Staffing Solutions Full time

    Ready to take your career to the next level? Join A-Line Staffing as an Inventory Specialist at a Department of Veteran Affairs Mail Order Pharmacy and play a key role in ensuring smooth pharmacy operations. If you thrive in a dynamic environment and enjoy hands-on work with cutting-edge automation technology, this is the perfect opportunity for you! What...

  • Clinical Support Specialist

    3 weeks ago

    Chelmsford, Massachusetts, United States Ansible Government Solutions Full time

    Ansible Government Solutions, a Service-Disabled Veteran-Owned Small Business (SDVOSB), is seeking Clinical Support Specialists to support a U.S. Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) facility. As a key member of our team, you will play a vital role in ensuring the timely and accurate fulfillment of prescriptions...

  • Community Living Specialist

    5 days ago

    Chelmsford, Massachusetts, United States Bridgewell Full time

    Job DescriptionThe Community Living Specialist will provide support and assistance to individuals in our Level 3 residential programs, helping them to develop their skills and achieve their goals. This role requires a highly motivated and compassionate individual who shares our commitment to empowering people with disabilities.You will work closely with our...

  • Registered Pharmacist

    3 months ago

    Chelmsford, United States Ansible Government Solutions Full time

    OverviewAnsible Government Solutions, LLC (Ansible) is currently seeking Registered Pharmacists (RPH) to support a U.S. Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) facility located at 10 Industrial Avenue, Chelmsford, MA 01824. Pharmacists support the CMOP mission by preparing prescriptions and packages in an accurate,...

  • Medical Cannabis Specialist

    3 weeks ago

    Chelmsford, Massachusetts, United States TGS Global Full time

    As a Medical Cannabis Specialist at TGS Global, you will play a critical role in providing exceptional customer service and ensuring that patients receive the correct medication for their specific needs.Job SummaryWe are seeking a highly motivated and compassionate individual to join our team as a Patient Experience Coordinator. In this role, you will be...

  • Registered Pharmacist

    4 months ago

    Chelmsford, United States Ansible Government Solutions Full time

    OverviewAnsible Government Solutions, LLC (Ansible) is currently seeking Registered Pharmacists (RPH) to support a U.S. Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) facility located at 10 Industrial Avenue, Chelmsford, MA 01824. Pharmacists support the CMOP mission by preparing prescriptions and packages in an accurate,...

  • Registered Pharmacist

    1 week ago

    Chelmsford, United States Ansible Government Solutions Full time

    Overview Ansible Government Solutions, LLC (Ansible) is currently seeking Registered Pharmacists (RPH) to support a U.S. Department of Veterans Affairs (VA) Consolidated Mail Outpatient Pharmacy (CMOP) facility located at 10 Industrial Avenue, Chelmsford, MA 01824. Pharmacists support the CMOP mission by preparing prescriptions and packages in an accurate,...

  • Medical Support Specialist, ConnextCare

    5 days ago

    Chelmsford, Massachusetts, United States ConnextCare Full time

    At ConnextCare, we are committed to delivering exceptional patient care and service. As a Clinical Support Specialist, you will be an integral part of our healthcare team, working closely with our clinical staff to provide high-quality patient care.Key Responsibilities:Assist with patient rooming, electronic charting, and vital sign recordingSupport clinical...