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Oxenham Group
Watertown, MA, United States
QUALIFICATIONS: - BS or MS in a scientific discipline with 7-10 years of direct experience in Quality Assurance and Regulatory Affairs within the Medical Device industry - Strong knowledge of FDA and global regulatory requirements (EU/UK Regulations, ICH Guidelines, Common Rule, 21 CFR 56, 45 CFR 46; ISO 13485, 21 CFR 820, 21 CFR Part 10, 21 CFR Pa
Job Source: Oxenham GroupBioTalent Ltd
Norwood, MA, United States
Summary: The Regulatory Affairs Manager is responsible for overseeing all regulatory activities within Advanced Instruments. This includes developing and implementing regulatory strategies for product approvals, leading the registration of products, ensuring compliance with global regulatory requirements, and managing the regulatory affairs team. T
Job Source: BioTalent LtdCatalyst Life Sciences
Canton, MA, United States
Opportunity to join a global medical instrumentation organization as they grow the regulatory team due to successful acquisitions and increases to their product portfolio. Focusing on existing products, you'll have global reach on ensuring they remain compliant with US, EU IVDR, and global regulations. Responsibilities: Lead and coordinate the tran
Job Source: Catalyst Life SciencesBioTalent
Norwood, MA, United States
Introduction BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organiz
Job Source: BioTalentGenabio Diagnostics
Bedford, MA, United States
Qualifications : degree or above in a relevant discipline required years of industrial experience in IVD or medical device FDA registration in Chinese preferred Tasks: and support new product 510k Submissions and support International Device Licensing and Registrations product development teams with new product submission requirements guidance on w
Job Source: Genabio DiagnosticsFoundation Medicine
Boston, MA, United States
Job Description About the Job The Manager, Regulatory Affairs is responsible for supporting the regulatory function and its activities, the development of regulatory strategy, and contributing the regulatory approval process (including US FDA and other regulatory authorities) for FMI products. The incumbent functions as the regulatory representat
Job Source: Foundation MedicineBioTalent
Norwood, MA, United States
Introduction BioTalent is representing a top-tier life sciences device manufacturer hiring a Regulatory Affairs Manager ensure compliance with global regulatory requirements while managing the regulatory affairs team. The role requires collaboration with product development, quality assurance, and other cross-functional teams to support the organiz
Job Source: BioTalentDeciphera Pharmaceuticals
Watertown, MA, United States
Company Description Deciphera is a biopharmaceutical company focused on discovering, developing and commercializing important new medicines to improve the lives of people with cancer. We are leveraging our proprietary switch-control kinase inhibitor platform and deep expertise in kinase biology to develop a broad portfolio of innovative medicines.
Job Source: Deciphera PharmaceuticalsBoston, MA, United States
Job Summary The Manager, Regulatory Affairs is responsible for defining and implementing regulatory strategies and submissions in support of new and existing market authorizations. Participate on cross-functional project teams and act as global regulatory advisor. This position will be supporting Infusion Systems within Regulatory Affairs.
** This is a hybrid position and requires working on-site 3 days per week in North Andover, MA. Responsibilities
Represent Regulatory on assigned product/project teams; establish and implement regulatory strategies that align with project objectives
Develop and execute regulatory plans for complex projects including new product development, new registrations, product modifications, maintenance of existing licenses, and ongoing compliance activities
Strategize and prepare local and global regulatory submissions for assigned projects
Monitor applicable regulatory requirements for products within area of responsibility and inform product/project teams of upcoming changes in applicable regulations and guidance documents
Perform gap analyses and propose solutions to ensure compliance with local and global regulations as well as internal and external standards
Establish and maintain appropriate communication within Regulatory and across other functions primarily at project level
Develop and document sound regulatory decisions and justifications
Interact with regulatory agencies for assigned projects/submissions as directed by supervisor; respond to (or help with) regulatory agency questions within defined timelines
Review and approve product labeling and advertising/promotional materials for compliance with applicable regulatory requirements
Review technical documentation for suitability to support regulatory applications
Act as regulatory project manager on assigned projects. Collaborate with subject matter experts and drive project team to achieve established regulatory submission timelines
Mentor and train other regulatory staff
Requirements
Bachelor's degree with minimum of 6 years' experience in a function such as regulatory, quality, or clinical in the life sciences industry, OR high school diploma with minimum of 8 years' experience in medical device or pharmaceutical regulatory affairs
Experience in authoring infusion system applications to FDA is highly preferred (e.g., pre-subs, 510(k)s, IDEs)
Sound regulatory and scientific knowledge
Experience and proven effective collaboration in a multicultural environment
Strong oral and written communication and presentation skills
Demonstrated interpersonal skills including strong negotiation skills
Ability to manage complex projects and timelines in a matrix team environment
Ability to independently identify compliance risks and escalate when necessary
Ability to lead and coach others
Additional Information
We offer an excellent salary and benefits package including medical, dental and vision coverage, as well as life insurance,
disability,401K
with company match, andwellness program.
Fresenius Kabi is an Equal
Opportunity/Affirmative
Action employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, national origin, citizenship, immigration status, disabilities, or protected veteran status.
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Email Alert for Manager, Regulatory Affairs - IV Therapy jobs in Boston, MA, United States
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