Regulatory Affairs Specialist II
5 days ago
Overview:Position Summary:Responsible for domestic and/or international registration and renewal activities for Werfen-labeled products. Related duties include participation on design and risk management teams, initiation of regulatory plans for both new products and significant product modifications, documentation of regulatory impact from device modifications, assistance in creating and maintaining Technical Files, labeling/advertising review and other regulatory work required to maintain domestic and international compliance.Responsibilities:Key AccountabilitiesEssential Functions:Responsible to participate on design and risk management teams in the Hemostasis group as the Regulatory representative and provide guidance on domestic and international requirements, including:Author and sign Regulatory Plans on regulatory requirements for worldwide submissions for new products and significant post-market modifications as part of design input.Author and sign Regulatory Determinations on worldwide registration impact for significant product modifications as a design output.Prepare new product registration packages and technical files (e.g. CE Mark, 510ks, Canadian licenses).Provide support materials for Milan Regulatory for other country registrations.Assist with product renewal packages to maintain country registrations.Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation.Identify and screen historical data or reports that could be incorporated into future regulatory submissions to assure compliance with current scientific and regulatory standards.Responsible for maintenance of Regulatory Database in SAP.Responsible to review marketing and sign promotional materials for signature by management (as appropriate).Responsible to review and sign labeling and Change Orders (as appropriate).Educate and train Werfen personnel on domestic and international country registration and labeling requirements to ensure that during product development, their requirements are understood and incorporated.Other assignments related to RA/QA to support Werfen requirements and prioritiesBudget Managed (if applicable):N/AInternal Networking/Key Relationships:To be determined based on department needsSkills & Capabilities:Requires superior communication skills (verbal and written)Proficiency with standard software (Word, Excel, PowerPoint, Adobe Acrobat etc.)Hands on experience working in a regulated environemnt following QMS systems.Previous experience and familiary with In vitro Diagnostics, software in medical device strongly preferred.Experience with SAP is a plus.Qualifications:Minimum Knowledge & Experience Required for the Position:Requires a Bachelor degree, preferably in life sciences or engineering familiarity with ISO 13485 and 14971 preferred.Two years minimum experience in the Medical Device Industry or other highly regulated environment.International Mobility: Required:NoTravel Requirements:Must be available to travel domestically and internationally as needed.
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Case Manager II
3 days ago
New Bedford, Massachusetts, United States Seven Hills Foundation Full time $30,000 - $60,000 per yearOverviewCase Manager IISeven Hills Family Services, An Affiliate of $Seven Hills FoundationAre you passionate about making a meaningful impact in the lives of others? We are looking for a Case Manager II to oversee the day-to-day operations of our Shared Living/Adult Family Care (AFC) programs. This role ensures the delivery of high-quality care and support...
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Health Technician
24 hours ago
New Bedford, Massachusetts, United States US Department of Veterans Affairs Full time $45,679 - $66,393 per yearSummaryThis Health Technician (Telehealth Clinical) position is located within the Primary Care Service line at the VA Providence Healthcare System's Middletown CBOC location. This position is full-time at 40 hours per week.This job is open toThe publicU.S. Citizens, Nationals or those who owe allegiance to the U.S.Internal to an agencyCurrent federal...
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Technical Support Specialist II: Hemostasis
3 days ago
New Bedford, Massachusetts, United States Werfen Full time $60,000 - $90,000 per yearOverviewPosition Summary:Under direction of the department manager, provides technical assistance to customers and Werfen field personnel within a product line responsibility. Troubleshoots, over the phone, answers a broad range of technical questions regarding instrument performance, instrument capabilities, QC concerns and other product concerns as...
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Pharmaceutical Customer Service Specialist
5 days ago
New Bedford, Massachusetts, United States Randstad Full timeWe're looking for an enthusiastic and customer-focusedCustomer Service Representativeto join our dynamic team If you have 1-3 years of customer service experience and a passion for helping others, this is the perfect opportunity for you. In this hybrid role, you'll enjoy the flexibility of working from home two days a week, while collaborating in the office...
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Behavioral Health Clinical Supervisor
5 days ago
New Bedford, Massachusetts, United States Cleanslate Centers Full time $50,000 - $80,000 per yearJob Details New Bedford MA - New Bedford, MA Athol MA - Athol, MA; Belchertown MA - Belchertown, MA; Falmouth MA - Falmouth, MA; Greenfield MA - Greenfield, MA; Holyoke MA - Holyoke, MA; Hyannis MA - Hyannis, MA Full Time $ $ Salary/year Up to 50% Description We're seeking an experienced and compassionate Senior Clinician to provide...
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Supervisor, QA Internal Operations
11 hours ago
New Bedford, Massachusetts, United States PCI Pharma Services Full time $80,000 - $120,000 per yearLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.JOB DESCRIPTION:Position Title: Supervisor, QA...
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Manager - Tech Services, MTS
1 day ago
New Bedford, Massachusetts, United States PCI Pharma Services Full timeLife changing therapies. Global impact. Bridge to thousands of biopharma companies and their patients.We are PCI. Our investment is in People who make an impact, drive progress and create a better tomorrow. Our strategy includes building teams across our global network to pioneer and shape the future of PCI.Summary of Objective:The Manager Process...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, United States Lexington Medical, Inc Full timeSenior Regulatory Affairs Specialist – Lexington Medical, IncJoin to apply for the Senior Regulatory Affairs Specialist role at Lexington Medical, Inc.Company OverviewLexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design...
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Regulatory Affairs Manager
4 weeks ago
Bedford, United States Pragmatic Full timeRegulatory Affairs Manager📍 4 days on-site | Bedford, MA 💼 Medical Device Company Commercial StageWere seeking a Regulatory Affairs Manager to support U.S. and international regulatory activities as the company moves through commercialization and prepares for global expansion.This position will collaborate closely with Quality, R&D, and senior...
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Senior Regulatory Affairs Specialist
3 weeks ago
Bedford, United States Lexington Medical Full timeLexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving $6B+ surgical...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Senior Regulatory Affairs Specialist
2 weeks ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Senior Regulatory Affairs Specialist
7 days ago
Bedford, MA, United States Lexington Medical, Inc. Full timeCompany Overview:Lexington Medical, Inc. is a medical device company developing and manufacturing minimally invasive surgical stapling solutions in the Boston area. With the highest standards in design engineering and smart manufacturing, our team delivers disruptive technology to healthcare providers, improving surgical outcomes for patients in a thriving...
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Vice President Regulatory Affairs
2 weeks ago
Bedford, United States Pragmatic Full time1 week ago Be among the first 25 applicantsGet AI-powered advice on this job and more exclusive features.Direct message the job poster from PragmaticPractical Recruitment. Life Changing ResultsVP or Head of Regulatory & QualityLocation: Bedford, MA (Hybrid, 4 days on site, 1 day remote)Industry: Medical DeviceEmployment Type: Full-time | Competitive...
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Regulatory Affairs Specialist
1 week ago
Bedford, MA, United States CEDENT Full timeResponsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA. Determine and document change...
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Regulatory Affairs Specialist
1 week ago
Bedford, MA, United States Cedent Full timeResponsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA. Determine and document change...
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Regulatory Affairs Specialist
1 day ago
Bedford, MA, United States Cedent Full timeResponsibilities: Determine and document change assessments for US Class II devices to ensure compliance with the US regulation. Plan and prepare submissions for US Class II devices, including creating, translating, revising, reviewing, and compiling documents, as well as responding to questions and requests from the FDA. Determine and document change...