Regulatory Affairs Manager / ...
RAPS Institute
Company Description Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than 9,000 professionals across 30+ offices, Collabera offers comprehensive, cost-effective IT staffing & IT Services. We provide services to Fortune 500 and mid-size companies to meet their talent needs with high quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged Advanced Staffing & Solutions) Permanent Placement Services and Vendor Management Programs. Collabera recognizes true potential of human capital and provides people the right opportunities for growth and professional excellence. Job Description Job Title: Regulatory Affairs Manager Duration: 06+ months (Possibility to Hire) Responsibilities The Regulatory Affairs Manager ensures compliance to FDA and other applicable regulations. In this role, you will lead the preparation, analysis, and submissions dossiers to various governing agencies in supporting business growth. The RA Manager supports compliance with applicable regulations including ISO, local, state, and/or federal requirements. Preparing international regulatory submissions and FDA submissions which may include device 510(k), IDEs, PMAs and serving as regulatory representative on selected project teams; developing departmental SOPs/policies regarding regulatory matters. Qualifications Bachelor's degree required. Scientific or engineering field preferred. 5+ years of medical device regulatory affairs experience. Must have authored 510(k) submissions. Must have knowledge of U.S. FDA regulations and standards. 3+ years of experience interacting with FDA and/or other regulatory agencies. Experience with devices containing software is strongly preferred. Solid understanding of manufacturing and change control, and an awareness of regulatory trends. Additional Information To know more on this position or to schedule an interview, please contact: Himanshu Prajapat View phone number on click.appcast.io himanshu.prajapat[@]collabera.com #J-18808-Ljbffr RAPS Institute
- Temp to Perm - Remote Opportunity - Regulatory Affairs Manager Established in 1991, Collabera has been a leader in IT staffing for over 22 years and is one of the largest diversity IT staffing firms in the industry. As a half a billion dollar IT company, with more than...SuggestedRemote jobPermanent employmentTemporary workLocal area
- 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...SuggestedPermanent employment
- 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
- ...reporting. Work with cross‑platform teams, Data Architects, Technical Managers and stakeholders. Support downstream applications. Resolve... ...Troubleshoot systems and applications. Ensure compliance with regulatory reporting requirements such as GDPR and CCPA. Implement AI...SuggestedContract workFor contractors
TRIPLECOM
Norwood, MA5 days ago - ...in the DePuy Synthes Strategic Medical Affairs Team for a wide range of audiences. Key... ...preparing, writing, editing, and reviewing regulatory (e.g. Clinical Evaluation Reports (CERs)... ...requirements, good clinical and data management practices. Ability to understand and interpret...SuggestedWork at officeRemote work
$117k - $201.25k
...dignity of our employees and recognize their merit. Job Function Regulatory Affairs Group Job Sub Function Regulatory Affairs Job Category... ...our DePuy Synthes Orthopaedics team as a Regulatory Affairs Manager. This position may be based in Raynham, MA; West Chester, PA...Local areaImmediate start- ...quality IT resources through Staff Augmentation, Global Talent Management, Value Added Services through CLASS (Competency Leveraged... ...plan, Life Insurance, Disability Insurance. Job Description Regulatory affairs with Technical Files, or equivalent in an R&D or quality position...Permanent employment
Collabera
Mansfield, MA4 days ago - ...Job title: Regulatory Affairs Specialist Location: Mansfield, MA Duration: 5+ months (possibility of extension) Roles and Responsibility The skills required include a Regulatory Affairs contracted professional with experience working on product development teams, familiarity...
Integrated Resources
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...manufacture technology that takes the limits off living. Are you a regulatory affairs professional who enjoys working at the intersection of... ...for new and modified medical devices Preparing and managing regulatory submissions to obtain and maintain global market...Local areaFlexible hoursSmith & Nephew
Mansfield, MA1 day ago- Johnson & Johnson MedTech is seeking a Senior Regulatory Affairs Manager to lead regulatory strategy for Orthopaedics products across multiple sites in the U.S. You will guide licensing, registrations, and submissions, interfacing with FDA and international agencies to...
- ...Compliance Associate in Mansfield, MA. You will support the site Quality Management System, assist with complaint handling and NC/CAPA processes, and help ensure documentation control and regulatory compliance across manufacturing and development teams. The role...
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NexDine is seeking a Benefits Manager in Mansfield, MA, to lead the strategy and administration of employee benefits. This full-time position offers a starting salary of $115,000 - $130,000 annually. The role requires strong leadership, compliance knowledge, and the ability...Full time$62.1k - $85.1k
....The **Quality Compliance Associate** supports the site Quality Management System (QMS) by performing routine quality system and compliance activities in accordance with internal procedures and regulatory requirements. Primary responsibilities include supporting complaint...Temporary workIntegra LifeSciences
Mansfield, MA3 days ago- A professional staffing agency is seeking a Regulatory Affairs Specialist in Mansfield, MA. The ideal candidate will have experience working with product development teams and must be knowledgeable in FDA regulations and medical device submissions. This role involves providing...
- A leading medical device company is seeking a Medical Writer Specialist to prepare regulatory documents and conduct scientific writing. This role demands a Ph.D/Pharm D or an equivalent degree with 1-2 years of relevant experience, or a BS/B.Pharm/BSN/MS/MPH with 4-5 years...Remote jobWork at office
- Regulatory Affairs Program Manager (Medical Device Divestiture) Location: Raynham, MA / West Chester, PA / Palm Beach Gardens, FL (Hybrid 3-4 days onsite) Duration: 12+ Months (Extension Possible) Overview We are seeking an experienced Regulatory Affairs Program Manager...
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The Role: The Associate Director, Global Regulatory-CMC will be responsible for coordinating regulatory CMC activities for one or more products... ...applications. The candidate will need to successfully manage multiple projects in a fast and results-oriented environment to...Permanent employmentWork at officeWork from home- Job Title Regulatory Affairs Program Manager Location Raynham, MA OR West Chester, PA OR Palm Beach Gardens, FL Hybrid Must be local willing and able to work onsite 3 or 4 days per week at one of the above locations. Duration 1 year plus extensions Contract Type W2...Contract workLocal area3 days per week
- ...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
- ...Resources Operations to lead HR functions across multiple states. This strategic role requires overseeing HR service delivery and managing a team while ensuring compliance across 17 states. Ideal candidates will have significant HR experience, strong leadership skills,...
- ...based health system or integrated delivery network. Success in improving patient experience, access, operational performance and regulatory compliance, and exposure to risk-based or value-based care environments, is helpful. The candidate must hold an MD or DO degree with...
- ...firm in Mansfield, Massachusetts is seeking a professional for a role in regulatory affairs. The candidate will be responsible for preparing and auditing medical device DHFs and risk management files while ensuring compliance with US and international regulations. The...
- Integra LifeSciences is seeking a Document Control Coordinator in Mansfield, MA to manage the document control program ensuring compliance with domestic and international medical device regulations. You will coordinate, process, and maintain controlled documents and training...
- Bausch Health Companies Inc. is seeking a Senior Director of Advertising & Promotion - Regulatory Affairs to lead regulatory reviews for prescription, OTC, and cosmetic products, primarily in the US with Canada support. The role ensures compliance with regulatory agencies...
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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...$224.9k - $404.6k
Moderna is seeking a regulatory CMC expert to manage a team at their Norwood, MA site. This key leadership role involves overseeing the product strategy for all portfolio products, managing regulatory submissions, and ensuring adherence to quality standards. Ideal candidates...$121k - $150k
...in everything we do. Job Summary The QA Automation Engineering Manager plays a pivotal role in leading ConnectPay’s QA automation... ...defects Stay current with industry trends, best practices, and regulatory changes affecting payroll and quality assurance Advocate for quality...Temporary workWork experience placementRemote workVisa sponsorshipRelocation packageFlexible hoursAmber Resort Rewal
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...and making headway to innovate new treatment pathways to advance patient outcomes and set new standards of care. Quality Compliance Manager, ECMP Site Facilitator Provides tactical support and oversight of the implementation of the Enterprise Compliance Master Plan at...Temporary workWork at officeLocal area$50 per hour
...Regulatory Affairs Resource Location: Raynham, MA Role/Responsibilities Provide regulatory guidance to product development teams in defining regulatory strategies, pre‑marketing, and related submissions to support optimal timelines for modified product launches in the...Hourly payLocal areaHCLTech
Raynham, MA3 days ago- ...organization for its Manufacturing and Testing Facility. This senior leadership role is accountable for maintaining compliance and managing operational excellence in GMP quality operations. The ideal candidate will bring over 15 years of progressive experience in the...
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