...and quality of the products conform to established standards and agency guidelines.Design, implement, and improve company quality management systems for medical device companies (ISO 9001, ISO 13485, 21 CFR Part 820 and MDSAP)Overseeing all QMS issues and concerns by... 
Suggested
Permanent employment

RBW Consulting

Cambridge, MA
1 day ago
 ...Together, we are leading the way towards a healthier and more equitable future. Position Summary As the Senior Manager of Regulatory Affairs, you will play a critical role in ensuring regulatory compliance and supporting the execution of our regulatory strategy... 
Suggested
Flexible hours

Editas Medicine

Cambridge, MA
3 days ago
 ...Job Summary The Director of Public Affairs will play a critical role in implementing external communications strategies that amplify...  ...and public affairs, and will play a critical role in issues management and crisis communications. S/he will cultivate and maintain... 
Suggested
Local area
3 days per week

Harvard University Kennedy School

Cambridge, MA
8 days ago
Title:Associate Director, Medical Affairs, Adult Cholestatic DiseasesCompany:Ipsen Biopharmaceuticals...  ...including poster presentations and publications (in conjunction with the Publication...  ...for adult cholestatic diseases.Manage Travel and Expense budget in keeping with... 
Suggested
Temporary work
Local area
Flexible hours

AAPC

Cambridge, MA
1 day ago
 ...Vice President, Head of Medical Affairs About the Company Dynamic biotechnology (BioTech) company specializing in targeted cancer...  ...in a lean organization. The candidate should be adept at managing a mix of direct reports and external consultants and vendors, and... 
Suggested

Confidential

Cambridge, MA
4 hours agonew
 ...Job Description Manager, Global Regulatory Affairs About This Role The Global Regulatory Affairs Manager, works closely with Global and Regional Regulatory Leads providing support for a variety of regulatory activities for development and marketed products... 
Suggested
Full time
Local area

Biogen

Cambridge, MA
21 days ago
JOB DESCRIPTION Job Title Senior Medical Affairs Manager Job Description Senior Medical Affairs Manager (Cambridge Hybrid...  ...trends/research and stakeholder interaction data into publication strategies, messaging, and tactical planning Partner with... 
Suggested
Remote job
Work visa

Philips

Cambridge, MA
a month ago
 ...Job Description Manager, Regulatory Affairs About This Role The Manager, Regulatory Affairs, works closely with the US Regulatory Lead and participates on cross-functional project teams and present the US regulatory position to senior management governance... 
Suggested
Full time
Local area

Biogen

Cambridge, MA
27 days ago
 ...The Role The Vice President, Medical Affairs will build and lead the medical affairs...  ...communications, KOL engagement, and publication strategy to support the broader MA vision...  ...and work effectively with all levels of management. Strategic mindset with ability to... 
Suggested
Local area
Immediate start

Third Harmonic Bio

Cambridge, MA
2 days ago
 ...is seeking a Director, Global Medical Affairs to spearhead Medical Affairs activities...  ...activities supporting the launch and lifecycle management of INT. This is an exciting time to...  ...presentations and peer reviewed publications. Create a roadmap for establishing effective... 
Suggested
Holiday work
Flexible hours

Moderna

Cambridge, MA
1 day ago
 ...Title: Director, Global Regulatory Affairs, Oncology Company: Ipsen Bioscience...  ...proactively proposed for project team and senior management decision making. Accountable for the...  ...and commercialization teams, Public Affairs, Legal, Investor Relations, etc.... 
Suggested
Temporary work
Local area
Worldwide
Flexible hours

Ipsen Pharma

Cambridge, MA
2 days ago
Job TitlePrincipal Regulatory Affairs SpecialistJob DescriptionPrincipal Regulatory Affairs Specialist- Software & Artificial Intelligence...  ...balancing the project risks to projects and the regulatory management team.Lead regulatory submission activities, and directly... 
Suggested
Remote job
Relocation
Work visa

Philips

Cambridge, MA
14 hours ago
 ...Description We're looking for an Associate Director of Regulatory Affairs , working in Pharmaceuticals and Medical Products industry...  ...to meet deadlines Excellent organizational and project management skills; demonstrated ability to prioritize multiple projects... 
Suggested
Flexible hours

PSG Global Solutions Careers

Cambridge, MA
1 day ago
 ...As a core member of multiple new product development teams, the Regulatory Affairs Specialist will provide timely and valued regulatory guidance (written and / or verbal) by owning the following tasks: 1. Advise internal stakeholders (marketing, manu Regulatory Affairs... 
Suggested

Randstad North America, Inc.

Cambridge, MA
12 hours agonew
 ...Description The Head of Global Medical Affairs will provide strategic leadership to...  ...and communication strategy Lead publication strategy and planning for Bicycle, define...  ...decision-makers in healthcare systems, managed care organizations, payers, and government... 
Suggested
Holiday work
Full time
Immediate start
Flexible hours

Bicycle Therapeutics

Cambridge, MA
7 days ago
 ...average 20 hours per week, preferably 4 hours a day M-F, but we can be flexible depending on the candidate. -REMOTE- Regulatory Affairs Specialist DS Process Expert with NDA filing experience. May September (20 hours week) Contractor to support regulatory... 
Contract work
For contractors
Remote job
Flexible hours

VALIDATION ASSOCIATES LLC

Cambridge, MA
7 days ago
 ...Senior Manager, Global Regulatory Affairs - US Strategy Your responsibilities may include: ~ Advise on US FDA procedures, requirements and administrative documentation ~ Establish and maintain transparent and collaborative relationship with the Agency... 
Hourly pay
Holiday work
Contract work
Work experience placement

Biontech

Cambridge, MA
29 days ago
 ...Description We're looking for an Associate Director Regulatory Affairs CMC , working in Pharmaceuticals and Medical Products...  ...global clinical development, registration, and product life cycle management Manages timely regulatory submissions that involve CMC... 

PSG Global Solutions Careers

Cambridge, MA
1 day ago
 ...Position Overview: VP/SVP, of Medical Affairs will be responsible for designing...  ..., including MSLs, Medical Communication/Publications/Education, Medical Information, Patient...  ...pipeline prioritization Develop and manage clinical advisors and KOL relationships,... 
Local area

Beam Therapeutics

Cambridge, MA
6 days ago
 ...opportunity for a Full Time Senior Vice President, Regulatory Affairs and Quality to lead regulatory strategy and quality systems for...  ...for preparing BLA/MAA submission, and part of the executive management team reporting to the CEO. At Beacon Therapeutics, you will make... 
Full time
Remote job
Work from home
Flexible hours

Beacon Therapeutics (USA) Inc

Cambridge, MA
11 days ago
 ...Locations: VA - Richmond, United States of America, Richmond, Virginia Manager, Cyber Product Owner - Cryptographic Services (Public Key Infrastructure) Capital One is seeking a product owner to help deliver game-changing cybersecurity solutions based on... 
Full time
Part time
Local area

Capital One

Cambridge, MA
26 days ago
 ...Responsibilities •Collaborate with colleagues in Commercial, Medical Affairs, Legal, Compliance and other expertise areas in creation of...  ...medical, and legal concepts and information •Experienced in managing individuals and/or teams preferred Ways of Working •Must... 
Flexible hours

Alnylam Pharmaceuticals

Cambridge, MA
14 hours ago
 ...Job Summary Alumni Affairs and Development (AA&D) Alumni Affairs and Development is a dedicated team supporting Harvard's advancement...  ..., alumni and volunteer engagement, technology, prospect management and research, business process, events, communications, and... 
Full time

Harvard University Alumni Affairs and Development

Cambridge, MA
2 days ago
 ...Job Description Job description: Accounting Manager- Remote Our client is a multi-generational family office service organization...  ...is required - Relevant experience includes tenure in a public accounting firm, investment accounting experience, prior involvement... 
Remote job

Job Juncture

Cambridge, MA
19 days ago
JOB DESCRIPTION Job Title Senior Regulatory Affairs Specialist Job Description Senior Regulatory Affairs Specialist...  ...processes together with cross-functional partners such as Quality Management, Regulatory Affairs, Clinical Affairs, etc. in order to... 
Remote job
Worldwide
Relocation
Work visa

Philips

Cambridge, MA
a month ago
 ...Job Summary Alumni Affairs and Development (AA&D) Alumni Affairs and Development is a dedicated team supporting Harvard's advancement...  ..., alumni and volunteer engagement, technology, prospect management and research, business process, events, communications, and... 
Flexible hours
Night shift
Weekend work

Harvard University Alumni Affairs and Development

Cambridge, MA
24 days ago
JOB DESCRIPTION Job Title Principal Regulatory Affairs Specialist Job Description Principal Regulatory Affairs Specialist...  ...opportunity to work closely with Clinical Affairs, Product Management and R&D to ensure its success. Your role: Ensure that... 
Local area
Remote job
Worldwide
Relocation
Work visa

Philips

Cambridge, MA
a month ago
 ...position. Applications may be periodically referred to hiring managers both during the open period and after the closing date. Because...  ...applications anticipated, applicants' status will not be updated. This public notice will be used to fill Public Notice for Expedited Hire (... 
Remote job
Permanent employment
Full time
Temporary work
Part time
Traineeship
Local area
Relocation
Trial period

Centers for Disease Control and Prevention

Cambridge, MA
3 days ago
 ..., conserve property, and build long term relationships with the public. We are proud to support public safety and community initiatives...  ...Assistant Director of Public Safety Information Technology will manage the PSIT team. This is a hands-on manager position working closely... 
Holiday work
Full time
Work experience placement
Remote job

City of Cambridge Massachusetts

Cambridge, MA
3 days ago
 ...Job Description FACULTY AFFAIRS ADMINISTRATOR , School of Science (SoS) , to administer and implement operational and administrative...  ...of PowerPoint presentations for the dean and associate deans; managing the SoS Teaching Prize program; administering faculty leaves... 

Massachusetts Institute of Technology (MIT)

Cambridge, MA
8 days ago