-
Regulatory Affairs Manager
2 weeks ago
Pramand LLC Bedford, United States**About Us**: · Pramand, LLC, is a medical device company based in Bedford, MA. We develop implantable medical devices from novel, proprietary hydrogel materials that improve patient outcomes while lowering the cost of therapy. We self-fund our projects through preclinical develo ...
-
Regulatory Affairs Manager
3 weeks ago
Genabio Diagnostics Inc. Bedford, United States**Qualifications**: · - Bachelor's degree or above in a relevant discipline required · - 5+ years of industrial experience in IVD or medical device FDA registration · - Proficiency in Chinese preferred · **Tasks**: · - Lead and support new product 510k Submissions · - Lead and su ...
-
Student Affairs Manager
1 week ago
Brown University Providence, United StatesJob Description: · The Student Affairs Manager oversees and manages the support of the Department of History PhD program. This work includes managing and taking a leadership role in the recruitment efforts, events, and managing the department's graduate programs academic scheduli ...
-
Global Medical Affairs Research Manager
1 week ago
Lantheus Medical Imaging Inc Bedford, United StatesJob Description · Job DescriptionLantheus is headquartered in Bedford, Massachusetts with offices in New Jersey, Canada, and Sweden. For more than 60 years, Lantheus has been instrumental in pioneering the field of medical imaging and has helped physicians enhance patient care wi ...
-
Food Service Worker
1 week ago
US Veterans Health Administration Bedford, United States**Duties**: · This position is located in the Nutrition and Food Services within the Department of Veterans Affairs Health Administration. The primary purpose of this position is to perform and lead employees in food service operations including food handling, preparation, storag ...
-
Communications Associate, Events and Digital
2 weeks ago
Werfen Bedford, United States**Job Overview**: · - Post Date · - April 17, 2024 · - Number · - ICIMS · - Job Function · - Marketing · - Location · - Bedford - 180 Hartwell Road Bedford, Massachusetts 01730 United States · - Country · - United States · **About the Position**: · **Overview**: · **Werfen** · W ...
-
Principal
1 week ago
St. Joseph School Fairhaven, United StatesSt. Joseph Catholic School, located in Fairhaven, MA, seeks a Principal with visionary leadership, passion, commitment, and effective educational skills ready to lead this vibrant PreK-Gr 8 Catholic school. · The mission of this Catholic school is focused on "providing a quality, ...
-
Business Affairs Manager
6 days ago
TALENT Software Services Providence, United StatesAre you an experienced Business Affairs Manager with a desire to excel? If so, then Talent Software Services may have the job for you Our client is seeking an experienced Business Affairs Manager to work at their company in CA(Remote). · Position Summary: Looking for a business a ...
-
Compensation Manager
4 days ago
Coca-Cola Northeast Bedford, United StatesCompensation: $90,000 - $100,000 annually dependent on experience · - Schedule: Normal business hours Monday - Friday, in-office role that sits in Bedford, NH · - Travel Requirements: Must be able to commute in office 5 days/wk and travel occasionally as needed throughout upstate ...
-
Student Affairs Manager
5 days ago
InsideHigherEd Rhode Island, United States Administrative Jobs ,Job Description:The Student Affairs Manager oversees and manages the support of the Department of History PhD program. This work includes managing and taking a leadership role in the recruitment efforts, events, and managing the department's graduate programs academic scheduling. ...
-
Government Affairs Manager
1 week ago
Hallo Healthcare Group Warwick, United StatesAbout The Role · This role will be a part-time or full time, · home based · role. · Do you want to lead on proactive campaigns? Are you comfortable rolling up your sleeves and getting stuck in? Do you want to build relationships with an array of internal and external stakehol ...
-
Student Affairs Manager
1 week ago
Brown University Providence, United States Full timeJob Description · : The Student Affairs Manager oversees and manages the support of the Department of History PhD program. This work includes managing and taking a leadership role in the recruitment efforts, events, and managing the department's graduate programs academic schedu ...
-
Student Affairs Manager
2 days ago
Brown University Providence, United StatesJob Description: · The Student Affairs Manager oversees and manages the support of the Department of History PhD program. This work includes managing and taking a leadership role in the recruitment efforts, events, and managing the departments graduate programs academic scheduli ...
-
Government Affairs Manager
1 week ago
Hallo Healthcare Group Warwick, United StatesAbout The Role · This role will be a part-time or full time, · home based · role. · Do you want to lead on proactive campaigns? Are you comfortable rolling up your sleeves and getting stuck in? Do you want to build relationships with an array of internal and external stakehold ...
-
Senior Manager Professional Affairs
1 week ago
Bausch Health Bridgewater, United StatesSolta, a division of Bausch Health, is committed to improving patients quality of life by delivering sophisticated technology in simple, elegant designs, providing true aesthetic and therapeutic benefits. For more than a decade, we've been developing innovative treatment technolo ...
-
Senior Manager Regulatory Affairs
2 weeks ago
Gan & Lee Pharmaceuticals Ltd Bridgewater, United StatesSummary · This position reports to the Functional Area Head, Global Regulatory Affairs. The incumbent responsible for supporting the development and implementation of regulatory strategies, work closely with the cross functional asset teams to prepare, review and submit regulator ...
-
Public Affairs Manager, Security Engineering
13 hours ago
META Providence, United StatesMeta · Public Affairs Manager, Security Engineering · Providence , · Rhode Island · Apply Now · Meta is looking for a Public Affairs Manager to join its Security Communications Team. In this role, you will support our cross-company information security efforts in developing ...
-
Workday Bridgewater, United StatesPosition Overview: · With minimal direction from the Therapeutic Area Head, will conduct the independent review of advertising, promotional, communications and other materials, and help develop and implement regulatory strategies for promotion and advertising campaigns, includin ...
-
Executive Assistant, Espn Legal
1 week ago
ESPN Bristol, United StatesWorking at ESPN is unlike anything else. That's because we're always finding new ways to interact with fans - however and wherever they connect with sports. Every day we're doing things that no one has done, all in a dynamic culture where we defy odds and continuously outdo ourse ...
-
Director of Public Affairs
1 week ago
State of Rhode Island Providence, United States**Class Definition**: · **G**E**NERAL STATEMENT OF DUTIES**: To lead and actively participate in the development and implementation of public affairs, communications strategies and messaging for the Department of Administration and other state agencies as assigned; to establish, ...
Regulatory Affairs Manager - Bedford, United States - Pragmatic
Description
About Our Client:
Our client revolutionizes patient care with cutting-edge hydrogel-based medical devices. Their commitment to self-funding projects, strategic partnerships, and innovative technology positions them as leaders in addressing unmet medical needs.
With over ten spin-off companies and a $4B value, their impact has positively affected over 5 million patients worldwide. Join us in celebrating their commitment to excellence in healthcare solutions
The Role
As the sole Regulatory Affairs Manager, you'll lead the charge in ensuring compliance with regulatory standards for our medical device products. Your role involves strategizing, preparing documentation, and liaising with regulatory agencies to secure marketing approval across different territories. Join us in shaping the future of healthcare compliance and innovation
Key Responsibilities
Formulate and execute regulatory strategies for timely product approvals. Provide regulatory guidance to cross-functional teams to support product development and commercialization.
Regulatory Submissions:
Prepare and submit regulatory documentation for Class III (PMA) and Class II (510(k)) devices.
Liaise with regulatory agencies to facilitate the review process.
Compliance Management:
Monitor and interpret changes to standards and regulations.
Manage ongoing compliance and collaborate with internal teams to address potential gaps.
Risk Management:
Collaborate with cross-functional teams to execute the Risk Management Process and Benefit-Risk Determinations.
Maintain facility registrations in good standing.
Requirements:
Deep understanding of FDA regulations and international medical device standards.
Expertise in quality management systems and regulatory submission processes.
A knack for clear, open communication, fostering collaboration in a fast-paced environment.
Stellar interpersonal skills, enabling seamless collaboration across departments. Ready to dive in and work on-site, making a tangible impact on our exciting projects.
Working Conditions:
Expectation to be in the office in Bedford, MA, core hours between days per week.
Excellent office environment and very productive space.
