Regulatory Affairs Specialist II - Submissions & Compliance
Anika Corporation
Anika seeks a Regulatory Affairs Specialist II in Bedford, MA to support regulatory submissions and authority interactions. You will prepare and submit documentation, support market approvals, and guide cross-functional teams to ensure compliance with regulatory requirements. Ideal candidates have 2+ years of regulatory affairs experience, with knowledge of FDA processes, 510(k)s, EU MDR docs, and post-approval activities. #J-18808-Ljbffr Anika Corporation
- Anika-GCC in Bedford, MA is seeking a Regulatory Affairs Specialist II to support regulatory submissions and regulatory authority interactions related to product submissions... ...guidance to cross-functional teams to ensure compliance with applicable requirements. #J-18808-Ljbffr...Suggested
$66k - $82k
What You'll Do The Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related to product submissions and approvals... ...guidance to cross-functional teams to ensure compliance with applicable requirements. How You'll...SuggestedFull timeImmediate start- Glaukos Corporation in Acton, MA, is seeking a Sr. Regulatory Affairs Specialist to lead the preparation of regulatory submissions for the U.S. and international markets. The role is hybrid and full-time, requiring a proactive regulatory mindset and collaboration with cross...SuggestedFull time
$101.6k - $131.9k
...Responsible for supporting regulatory activities regarding... ..., MDR investigations submissions, post market risk... ...assist in post market compliance activities, including... ...of direct Regulatory Affairs experience is required... ...Files, Canadian Class II and III licenses, STED...SuggestedShift work- The Sr. RA Specialist is Responsible for preparation of regulatory submissions (domestic and foreign). Ensure implementation and... ...maintenance of regulatory filing in compliance with applicable regulations... ...with other basic Regulatory Affairs functions, such as scanning...SuggestedLocal area
- ...Senior Regulatory Affairs Specialist BrioHealth Solutions is seeking a skilled and self-motivated... ...studies and regulatory planning and submission activities. What You'll Do... ...marking, technical documentation, GSPR compliance, UDI/EUDAMED data, and Notified Body...
- ...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... ...and compiling documents for submission to regulatory authorities, as well as assisting in...Worldwide
- ...and development organization, seeks a Government Accounting & Compliance Analyst 2 in Cambridge, MA. You will ensure compliance with federal... ...Responsibilities include policy development, monitoring, and submission support, with potential security clearance requirements. #J-1...
- ...This position is intended to provide Regulatory Affairs support to FUJIFILM Healthcare Americas... ...This position supports full, ongoing compliance to all applicable U.S. Food and Drug Administration... ...notification and approval information submission to regulatory authorities or...Local areaRemote workFlexible hours
- Sr. Regulatory Affairs Specialist role at Glaukos Corporation Sr. Regulatory Affairs Specialist (Hybrid... ...for preparation of regulatory submissions (domestic and foreign). Ensure implementation... ...maintenance of regulatory filing in compliance with applicable regulations and...Full time
- Draper is seeking a Government Accounting & Compliance Analyst 2 in Cambridge, MA to ensure government contracting compliance and accurate... ...accounting. You will interpret federal regulations, support submissions, and collaborate with internal audit, contracts, procurement,...
- ...a skilled professional to join their Regulatory Affairs Operations team. The candidate will be... ...maintaining regulatory filings while ensuring compliance with all necessary standards. Ideal... ...will have at least four years of submission publishing experience and a relevant bachelor...
- ...contingent labor as a variable cost.Job Description• The Regulatory Affairs Operations (RA Ops) submission group is organized to provide submission development... ...regulated environment. • She/he also ensures that compliance standards are met for receipt and delivery of...Immediate start
$94k - $150k
Job TitleSenior Regulatory Affairs SpecialistJob DescriptionSenior Regulatory Affairs Specialist, UltrasoundThe Senior Regulatory Affairs... ...and preparing regulatory submission documents for agencies such... ...Philips values and ensure compliance with all relevant business...Full timeWork at officeImmediate startWork visaRelocation package3 days per week- Job SummaryThe Sr. Associate, Compliance is responsible for overseeing vendor management and... ...vendor-supplied products comply with regulatory and quality standards.Develop and maintain... ...cause analysis, and QA closure of Stage II OOS investigations and OOT investigationsWork...
- ...Regulatory Affairs Associate Integrated Resources, Inc is a premier staffing firm recognized... ...Description Job Title: Sr. Associate II Regulatory Affairs Location: Cambridge,... ...JOB ROLES & RESPONSIBILITIES Regulatory Submissions (CTA) Associate (Sr. Associate II level...
- Job DescriptionMIT Lincoln Laboratory is a Department of Defense Federally Funded Research and Development Center (FFRDC) engaged in the development and demonstration of advanced prototype technologies and systems, with an overall objective to transfer those capabilities...Contract workWork at office
- ...industries, our client is seeking a regulatory professional who can thrive... ...-functional teams to ensure compliance, quality, and successful... ...end‑to‑end regulatory submissions through detailed reviews of... ...of experience in regulatory affairs or quality engineering within...Worldwide
- ...Wilmington, Massachusetts, is looking for a regulatory professional to manage and resolve regulatory information requests, ensuring compliance across various products. This role will... ...5 years of experience in regulatory affairs within the medical device sector, with a...
$135.3k - $202.9k
...the globe.Scope: The Regional Regulatory Lead is responsible for the... ...-team.Drive the regulatory submission in your respective region. Ensure... ...to ensure ongoing compliance. Partner with Regulatory Project... ...least 5 years of regulatory affairs strategy experience in drug...Local areaFlexible hours3 days per week- ...Harvard’s Office of Research and Academic Compliance (ORAC) within the Office of the Vice... ...management, and compliance with all applicable regulatory, funder, and university requirements.... ...within grant applications prior to submission to sponsor for risk of foreign...Work at office
$160.2k - $240.4k
...not offer sponsorship for work authorization. External applicants must be eligible to work in the US. Your Role:In your role as Compliance Officer in the Global Life Science, Electronics & Enabling Functions team, you will serve as a trusted business counsellor across...Work at office$21.75 - $24.88 per hour
Job ID: 292233 Store Name/Number: MA-Burlington (0334) Address: 75 Middlesex Turnpike #1061, Burlington, MA 01803, United States (US) Hourly/Salaried: Hourly (Non-Exempt) Full Time/Part Time: Part Time Position Type: Regular Your Role at Sephora: As...Hourly payFull timePart timeFlexible hoursShift workNight shiftWeekend work- ...About the job Global Trade Compliance Coordinator Job Summary Develop, implement, and enforce policies and procedures globally... ...with key stakeholders to take corrective actions. Monitor regulatory changes globally and advise of risks, potential impact, and...Work at officeLocal area
$105k - $130k
...IT Compliance Analyst Billerica, MA (Hybrid) Quanterix is a global leader in ultra-sensitive biomarker detection, enabling breakthroughs... ..., processes, and controls meet internal policies and external regulatory requirements. This role contributes to maintaining compliance...Work at officeWork from home- ...us to be a powerful contributor and connector of right Talent. Job Description This individual will be part of the Global Regulatory Affairs team and assists with planning, writing, compilation, and editing of periodic regulatory reports (i.e. DSURs, orphan annual updates...
- ...client, a growing biopharma company, is seeking a Regulatory Affairs Specialist to support regulatory strategy and submission activities as the company advances its... ...organization Pandologic. Keywords: Regulatory Compliance Specialist, Location: Cambridge, MA - 02238 ,...Shift work
- ...Nova Biomedical is seeking a QA Specialist to strengthen our Quality Management System and ensure regulatory compliance across our operations in Massachusetts. You will coordinate... ...Manufacturing, Engineering, Regulatory Affairs and Quality Control. Ideal candidates have...
$147.4k
Posting Description SENIOR LICENSING AND BUSINESS DEVELOPMENT OFFICER, Technology Licensing Office, is responsible for the commercialization of MIT’s IP portfolio arising from research and activities on MIT’s campus; managing a large portfolio of cases, including, technology...Full timeWork at officeVisa sponsorship$120.44k
...closely and coordinates with other TLO staff throughout the lifecycle of the technology including Transactions, IP Portfolio Managers, Compliance, Operations and Finance teams. Job Requirements REQUIRED: Minimum of Bachelor’s degree in scientific, technical or business field...Permanent employmentFull timeWork at officeVisa sponsorship
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