Regulatory Affairs Specialist
12 hours ago
Nova Biomedical is seeking a highly skilled Regulatory Affairs Specialist to join our team in Waltham, MA. As a key member of our regulatory team, you will be responsible for ensuring company compliance with US 510k, Health Canada Licensing, International Device Submissions, Licensing and Registration requirements, ISO/FDA QSR, IVDD, ISO 13485, and quality system auditing.
Key Responsibilities:- Lead and support US 510k Submissions
- Lead and support Health Canada Device License Applications
- Lead and support International Device Licensing and Registrations
- Support product development teams for new product submission requirements
- Product Technical Files development and maintenance
- Review and approval of ECOs related to assigned projects
- Participate in Quality System Audits
- Technical writing
- Support UDI labeling project
- BS Degree in Sciences, or equivalent MS in Regulatory Affairs is preferred
- 2+ years (Level II) or 3+ years (Sr. Level) IVD experience
- Previous experience with 510k, Health Canada, International Device Submissions Licensing and Registration experience
- ISO/FDA QSR, IVDD/IVDR, ISO 13485 knowledge
- Excellent technical writing skills
- Quality system auditing experience is preferred
- Statistics and data base management proficiency preferred Certified Quality Auditor and RAC Certification are pluses
Nova Biomedical values mutual respect, honesty, and integrity. We offer a strong sense of family in the workplace, with one third of our employees having been with us for over 10 years. Our benefits include Blue Cross Blue Shield medical plan, tuition reimbursement, matching 401K, company subsidized cafeteria, and an innovative scholarship program for children of employees.
-
Senior Manager of Regulatory Affairs
4 weeks ago
Watertown, Massachusetts, United States Thermo Fisher Scientific Full timeWork ScheduleStandard (Mon-Fri)Environmental ConditionsOfficeJob OverviewAt Thermo Fisher Scientific, you will engage in impactful work that contributes positively on a global scale. Join our dedicated team in realizing our Mission daily, empowering our clients to enhance global health, safety, and environmental standards. We equip our global workforce with...
-
Government Affairs Specialist
3 weeks ago
Watertown, Massachusetts, United States Global Partners Full timeAbout the RoleWe are seeking a highly skilled Government Affairs Specialist to join our team at Global Partners. As a key member of our organization, you will be responsible for developing and implementing strategies to advance our legislative and political agenda.Key ResponsibilitiesDevelop and implement advocacy strategies to advance key priorities and...
-
Regulatory Intelligence Manager
4 days ago
Watertown, Massachusetts, United States Apellis Full timeJob SummaryWe are seeking a highly skilled Regulatory Intelligence Manager to join our team at Apellis Pharmaceuticals, Inc. As a key member of our Global Regulatory Operations team, you will play a critical role in conducting regulatory intelligence gathering, consolidation, and communication activities to support our global product teams.Key...
-
Senior Manager of CMC Regulatory Compliance
4 weeks ago
Watertown, Massachusetts, United States Alkermes Full timePosition Overview At Alkermes, we are dedicated to advancing the lives of individuals facing serious mental health challenges and addiction through innovative science and compassionate care. As a leader in the biopharmaceutical industry, we are proud of our diverse portfolio, which includes marketed products aimed at treating addiction and schizophrenia,...
-
Senior Medical Affairs Director
3 weeks ago
Watertown, Massachusetts, United States Dyne Therapeutics Inc Full timeAbout Dyne Therapeutics IncDyne Therapeutics Inc is a clinical-stage biotechnology company focused on developing innovative therapeutics for people living with genetically driven diseases.Job SummaryThe Senior Medical Affairs Director will be responsible for leading the medical affairs team in the US, providing strategic medical guidance and support to the...
-
Regulatory Compliance Specialist
3 weeks ago
Watertown, Massachusetts, United States Theraplant Full timePosition: Compliance Cure Specialist Reports To: Compliance Cure SupervisorJob Overview: At Theraplant, our Compliance team plays a crucial role in ensuring the integrity of the medical cannabis supply chain, adhering to the regulations set forth by the State of CT's Medical Marijuana Program. Compliance Officers are tasked with maintaining comprehensive...
-
Head of Medical Strategy
3 weeks ago
Watertown, Massachusetts, United States Dyne Therapeutics Inc Full timeAbout Dyne Therapeutics IncDyne Therapeutics Inc is a clinical-stage biotechnology company focused on developing innovative therapeutics for people living with genetically driven diseases.Job SummaryThe Senior Medical Affairs Director will be the medical leader responsible for the overall leadership and management of our medical affairs team in the US. This...
-
Environmental Services Specialist
2 weeks ago
Watertown, Massachusetts, United States Veolia Environnement SA Full timeJob SummaryWe are seeking a highly skilled Environmental Services Specialist to join our team at Veolia Environnement SA. As an Environmental Services Specialist, you will be responsible for providing specialized transportation and disposal services to our clients, ensuring compliance with state and federal environmental, health, and safety regulations.Key...
-
Senior Director of Process Chemistry
4 days ago
Watertown, Massachusetts, United States HireMinds: Specialized Recruiting in Life Sciences, Marketing, F Full timeSenior Director, Process ChemistryOur client, a mid-sized public company with approved products on the market, is seeking an experienced Process Chemistry leader to drive chemical process development and manufacturing strategy. Located in the suburbs of Boston & Cambridge, this role will lead a team of chemists and serve as a technical expert in drug...
-
Clinical Supply Chain Manager
4 weeks ago
Watertown, Massachusetts, United States Syndax Pharmaceuticals Full timeCompany Overview:Syndax Pharmaceuticals is dedicated to creating a future where individuals battling cancer can enjoy extended and improved lives. As a clinical-stage biopharmaceutical organization, we are focused on developing a groundbreaking pipeline of cancer treatments.Position Summary:The Clinical Supply Chain Manager will play a pivotal role in...
-
Senior Director of Process Chemistry
1 week ago
Watertown, Massachusetts, United States HireMinds Full timeProcess Chemistry Leadership OpportunityHireMinds is seeking an experienced Process Chemistry leader to join our client's team in the Greater Boston area. As a key member of the CMC team, you will be responsible for designing, executing, and leading chemical process development and manufacturing strategy to produce drug substances for GLP toxicology,...
-
Watertown, Massachusetts, United States HireMinds Full timeJob SummaryHireMinds is seeking an experienced Senior Director, Process Chemistry and Development to lead our team in designing, executing, and leading chemical process development and manufacturing strategy to produce drug substances for GLP toxicology, clinical supplies, and potential commercialization.Key ResponsibilitiesLead Process Chemistry and...
-
Foreman - Utility Installation Specialist
3 weeks ago
Watertown, Massachusetts, United States Gpac Full timeForeman - Utility Installation SpecialistWe are seeking a skilled and experienced Foreman to lead our Utility Installation team. As a key member of our team, you will be responsible for overseeing and guiding our crews in executing projects that bring essential utilities to life.Key Responsibilities:Lead and manage a team of utility installation...
-
Laboratory Operations Specialist
4 days ago
Watertown, Massachusetts, United States New York Cancer & Blood Specialists Full timeOvernight Laboratory AssistantAt New York Cancer & Blood Specialists, we're dedicated to providing exceptional care to our patients. As an Overnight Laboratory Assistant, you'll play a vital role in ensuring the smooth operation of our laboratory services.Key Responsibilities:Operate and maintain laboratory equipment, including centrifuges and processing...
-
Legislative Relations Manager
3 weeks ago
Watertown, Massachusetts, United States Global Partners Full timeAbout the RoleWe are seeking a highly skilled Government Affairs Specialist to join our team at Global Partners. As a key member of our organization, you will be responsible for developing and implementing strategies to advance our legislative and political agenda.Key ResponsibilitiesDevelop and implement advocacy strategies to advance key priorities and...
-
Senior Biostatistics Executive
4 weeks ago
Watertown, Massachusetts, United States Vigil Neuroscience, Inc. Full timePosition OverviewVigil Neuroscience, Inc. is pioneering the development of microglia-focused therapeutics aimed at addressing both rare and prevalent neurodegenerative disorders. Our mission is to enhance the functionality of microglia, the brain's immune system cells, to improve patient outcomes and support their families.We are in search of an exceptional...
-
Quality Assurance Specialist
2 days ago
Watertown, Massachusetts, United States Talnt Full timeJob Title: Quality Assurance SpecialistAt Talnt, we are seeking a highly skilled Quality Assurance Specialist to join our team. As a key member of our quality assurance team, you will be responsible for ensuring the highest standards of quality and safety in our food manufacturing processes.Key Responsibilities:Develop and maintain internal policies and...
-
Corporate Counsel, Litigation Specialist
2 weeks ago
Watertown, Massachusetts, United States Global Partners Full timeAbout the RoleWe are seeking a highly skilled Corporate Counsel, Litigation Specialist to join our team at Global Partners. This is an exciting opportunity for a talented lawyer to provide expert legal counsel and support to our business operations.Key ResponsibilitiesPartner with our external counsel to manage litigation involving contract, personal injury,...
-
Medication Administration Specialist
3 weeks ago
Watertown, Massachusetts, United States Avera Full timeJoin the Avera Team:Award-Winning Healthcare Provider:Avera has been recognized as one of the top 15 Health Systems in the nation, featured on Forbes' list of America's Best-in-State Employers, and acknowledged as a Level 10 Most Wired Health Care Organization by CHIME.Our Culture:Become part of a collaborative team dedicated to compassion and the mission of...
-
Lead Molecular Laboratory Specialist
4 weeks ago
Watertown, Massachusetts, United States Bio-Techne Full time**Join Bio-Techne, a leader in the Bio-Tech industry, and contribute to pioneering research in liquid biopsies. Our commitment to advancing clinical diagnostics through innovative technologies sets us apart.****Work Schedule:** Monday to Friday, with potential for Saturday shifts.**Position Overview**As a key member of our Clinical laboratory team, you will...