Regulatory Affairs Manager: FDA Submissions & Compliance
Collabera
A leading IT staffing firm in Massachusetts is seeking an experienced Regulatory Affairs Manager to ensure compliance with FDA and other regulations for medical devices. This role requires a minimum of 5 years in regulatory affairs, including experience with 510(k) submissions and interaction with FDA. The candidate should possess a Bachelor's degree in a scientific or engineering field and have a solid understanding of manufacturing and change control. This position offers the potential for permanent employment after an initial 6-month period. #J-18808-Ljbffr Collabera
- A leading IT staffing firm is seeking a Regulatory Affairs Manager for a remote opportunity. The role involves ensuring compliance with FDA regulations, leading regulatory submission processes including 510(k)s, and developing regulatory strategies for product development...SuggestedRemote job
$224.9k - $404.6k
Initial Therapeutics, Inc. is seeking a CMC Regulatory Manager based in Norwood, MA. The role involves leading a team of CMC experts to develop and implement regulatory strategies, ensure submission readiness, and manage interactions with health authorities. Ideal candidates...Suggested- Temp to Perm - Remote Opportunity - Regulatory Affairs Manager Established in 1991, Collabera has... ...Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.... ...lead the preparation, analysis, and submission of dossiers to various governing agencies...SuggestedRemote jobPermanent employmentTemporary workLocal area
- Regulatory Affairs Manager / Regulatory Affairs Specialist role Established in 1991, Collabera has... ...Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations.... ...lead the preparation, analysis, and submissions dossiers to various governing agencies...SuggestedPermanent employmentLocal area
- ...platform teams, Data Architects, Technical Managers and stakeholders. Support downstream... ...data warehousing issues ensuring compliance with data quality standards. Develop and... ...and applications. Ensure compliance with regulatory reporting requirements such as GDPR and...SuggestedContract workFor contractors
$178k - $307.05k
Sr. Director, Regulatory Law (DePuy Synthes) Location:... ...counsel on regulatory submissions, product clearances and... ...Partner with Regulatory Affairs and Quality leadership... ...interpret and apply FDA, EU MDR/IVDR, and other... ...to assess regulatory compliance or risk associated with...Immediate start$178k - $307.05k
...a Sr. Director, Regulatory Law, located in Raynham... ...with Regulatory Affairs, Quality, R&D,... ...innovation, compliance, and sustainable... ...counsel on regulatory submissions, product clearances... ...and apply FDA, EU MDR/IVDR, and... ...Laws, Compliance Management, Corporate Governance...Immediate start$178k - $307.05k
DePuy Synthes is seeking a Sr. Director, Regulatory Law to join their team in Raynham, MA. This... ...of legal experience with deep knowledge of FDA regulations. The position involves advising on regulatory submissions and compliance while leading risk assessments and...- ...cost. Job Description The Regulatory Affairs Operations (RA Ops) submission group is organized to... ...She/he also ensures that compliance standards are met for receipt... ...submissions through the FDA Gateway. Ensure... ...Software (sCubed and/or eCTD Manager), Validation Tools and...Immediate start
- ...Products Inc. is looking for a Sr. Director, Regulatory Law to serve as the leading legal... ...will provide strategic counsel, ensuring compliance with regulatory standards and guiding... ...experience, you will advise on regulatory submissions, monitor changes in law, and...
$105.1k - $150.1k
...The Regulatory Affairs (RA) Manager of Global Labeling Compliance leads the end-to-end alignment of medical device labeling, packaging, and digital assets with evolving... ...from diverse global authorities (e.g., FDA, EU MDR) and environmental directives (e.g., WEEE,...Full timeTemporary workWork experience placementLocal areaImmediate startRemote workWorldwideFlexible hours$224.9k - $404.6k
...Norwood, MA site and will be responsible for managing a team of CMC experts that prepare and... ...related agency correspondence and regulatory applications. This position will be required... ...CMC regulatory strategies for submissions (e.g. IND/CTA/BLA/MAA) and identify regulatory...Permanent employment$90k - $210k
...motivated Director, Quality Compliance to lead the quality compliance... ...identifying and assessing regulatory and quality risks during site... .... This individual will manage continuous inspection readiness... ...experience in preparing regulatory submissions and response to health...- ...with safety regulations and company policies. The role involves conducting safety inspections, developing training programs, and managing emergency response plans. Applicants should have a Bachelor’s degree in occupational health or a related field, experience in manufacturing...Work at office
$142.4k - $213.6k
...Strategic Communications Manager - Nam Secure Power & Services Schneider Electric has a new opening for a Strategic Communications... ...media, thought leadership, employee communications, and public affairs. External Communications Develop and maintain robust...Ongoing contractFull timeTemporary workFlexible hours- A major utility company in Massachusetts is seeking a skilled regulatory leader to direct distribution regulatory strategies. Candidates... ...The role also demands strong financial acumen and the ability to manage competing priorities effectively. This position supports a...Work at office
$109.25k - $149.5k
## Quality Compliance Manager, ECMP Site FacilitatorApplylocations: US-MA-Mansfield-190-Facilitytime type: Full timeposted on: Posted 2 Days... ...remediation programs, and working with compliance frameworks such as FDA, ISO 13485, and EU MDR.* Demonstrated management and...Temporary workWork at officeLocal area$137.6k - $180k
Associate Director, Regulatory Affairs Advertising and Promotion... ...(s): None Areas Managed: Advertising & Promotion... ...complex regulatory compliance requirements. Essential... ...Promotion) on Form FDA 2253 in a timely manner... ...requirements and e-submission formats/processes of...Full timeTemporary workPart timeNight shiftWeekend work$120k
...Description: Job Title: Director of Compliance Support Location: Corporate Office -... ...HallKeen is a mission-driven real estate management and investment firm dedicated to providing... ...teams succeed while maintaining regulatory excellence. Position Overview:...Full timeTemporary workWork at officeLocal area$159.8k - $177.55k
...function to drive competitive bid management and pricing strategies for high‑profile... ..., indirect costs, overheads, and regulatory considerations. Cross‑Industry &... ...regulatory frameworks and compliance requirements in bid submissions. Work closely with internal and external...For contractorsH1bWork at office- ...Director of Baseball Operations. This senior leadership role oversees all aspects of the baseball program, including scholarship management, fundraising, and donor engagement. The ideal candidate requires a Bachelor's degree and two years of experience, possessing knowledge...Afternoon shift
- Legend Biotech USA is seeking a Director, Ethics & Compliance Business Partner to join the Compliance team in Bridgewater, NJ. This role... ...the pharmaceutical industry, preferably with strong project management and communication skills. #J-18808-Ljbffr Legend Biotech USA
$178k - $307.05k
Johnson & Johnson seeks a Sr. Director, Regulatory Law in Raynham, MA, to provide expert legal... ...will lead legal strategies, ensuring compliance, product clearance, and risk mitigation.... ...communication skills, and proficiency with FDA regulations. The role includes...- ...ensuring effective stewardship of sponsored funds and enhancing compliance and oversight. The ideal candidate will oversee financial... ...are required, with a preferred master's degree and familiarity with financial management tools. #J-18808-Ljbffr University of California
- ...is looking for an Associate Director, Document Management to lead document management strategies and ensure compliance within the organization. The position involves... ...overseeing document management processes and regulatory readiness. The ideal candidate should have over...
$145.09k - $161.21k
...Responsible for implementing strategic regulatory initiatives and developing and building... ...ensure that it conforms to what regulatory affairs wants. Interacts with Low Income... ...building relationships, leading change, and managing complex projects. Utility industry experience...H1bWork at officeRemote work$97k - $140k
iconectiv is hiring for an accounting role focused on vendor management and compliance in Bridgewater, NJ. Applicants should have over 10 years of experience in accounting operational environments, a Bachelor's degree preferred, and knowledge of Netsuite ERP. The expected...$171.5k - $207.5k
...and saving lives. JOB SUMMARY The Sr. Manager, QA Compliance is a senior site Quality leader... ...accountability for internal audit programs, regulatory inspection preparedness and execution,... ...global standards, regulatory expectations (FDA/CBER and global health authorities),...Local area$150k - $300k
...in healthcare innovation, is seeking a Compliance DS Director to oversee the entire DPS GS... ...plans across DPS, ensuring statutory, regulatory and SOX control requirements are addressed... ...ERPs preferred. Project/program management skills (planning, risk management, stakeholder...Local area- ...leadership ensuring effective stewardship of sponsored funds and high-quality service for researchers. The ideal candidate will oversee compliance with regulations, lead process improvements, and mentor staff. This exempt position involves a hybrid work model and requires...
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