Regulatory Affairs Specialist
ProKatchers
Job Title : Regulatory Affairs Specialist II Location : South Portland, ME 04106 Duration : 08 Months Education : High School Job Description : Responsible for technical writing of files in accordance with In Vitro Diagnostic medical device Regulation (IVDR). Provides regulatory support for diagnostic product development and commercial diagnostic products. Develops regulatory strategies for products in development and for modified products to achieve clearance/approval in the EU and internationally. Provides regulatory support to regional regulatory teams to assist with submissions, license renewals, and license amendments. Researches and communicates scientific and regulatory information in order to write submission documents. Compiles and publishes all material required for submissions, license renewals, and annual registrations. Maintains approvals/licenses/authorizations for existing marketing authorizations. Assesses product, manufacturing, and labeling changes for regulatory reporting impact and compliance to regulations. #J-18808-Ljbffr
Vacancy posted 1 day ago
Similar jobs that could be interesting for youBased on the Regulatory Affairs Specialist in South Portland, ME vacancy
$113.1k - $133.7k
About the Team / Role Reporting to the Director, Corporate Compliance, the Regulatory Compliance Analyst 4 will assist with the coordination and integration of Corporate Compliance activities to meet all relevant requirements, ensuring compliance and alignment with business...SuggestedFlexible hours- ...A leading pharmaceutical company is seeking a Regulatory Affairs Specialist II to prepare documentation for EU Technical Files and international product registrations. Applicants should possess a Bachelor's degree in a related technical field and have over 4 years of experience...Suggested
Planet Pharma
South Portland, ME1 day ago $73k - $78k
A leading housing compliance organization is seeking a Compliance Specialist responsible for ensuring compliance within multi-state affordable housing properties. The ideal candidate will work remotely, conducting site visits as needed, and must have certifications in...SuggestedFull timeRemote workA Hiring Company
Portland, ME2 days ago$60k
The Opportunity This position uses independent judgement and discretion to ensure all Registered Representatives adhere to regulatory standards and ACA Foreside compliance policies. The position will include serving as a primary interface with our Registered Representatives...SuggestedWork experience placementSummer workWork at officeFlexible hours- ...communities where we live. We aim to bring warmth and energy to everything we do. We are pleased to offer an exciting opportunity for a Regulatory and Rates Analyst to work in a hybrid capacity from one of our offices in Arkansas, Maine, Oklahoma, or remotely from Texas....SuggestedWork experience placementWork at officeRemote workWork from home
$115k - $135k
This is a remote based position. Applicants can be located nationwide Back Senior Program Analyst, EDI Project Coordinator #2812 United States Apply X Facebook LinkedIn Email Copy Position Description About You You are a person who loves to analyze complex program...Full timeTemporary workRemote workMonday to FridaySignature Performance
Portland, ME3 days ago- Chief Nursing Officer (CNO) About the Company Prominent provider of high-quality inpatient rehabilitation services Industry Hospital & Health Care Type Non Profit About the Role The Company is in search of a Chief Nursing Officer (CNO...
Confidential
Portland, ME1 day ago - Chief Nursing Officer (CNO) About the Company Prominent provider of inpatient rehabilitation services Industry Hospital & Health Care Type Privately Held About the Role The Company is seeking a Chief Nursing Officer (CNO) to join their dynamic team...
$116.86k - $156.05k
About Us At ENFRA, we blend a rich history with a forward-looking vision. With over 100 years of experience, we are a pillar of stability in the energy infrastructure industry and a leader in innovative energy solutions. Our commitment to leveraging emerging technologies...Full timeContract workFor subcontractorWork at officeRemote workENFRA
Portland, ME4 days ago$102.17k
Company Overview Check out this video and find out why our team loves to work here! ( Join Us! CDM Smith – where amazing career journeys unfold. Imagine a place committed to offering an unmatched employee experience. Where you work on projects that are meaningful...Work experience placementH1bWork at officeRemote workCDM Smith
Portland, ME4 days ago$75.04k - $112.56k
...compliance tools and applications, management of compliance reporting, and delivery of program support to meet both internal and external regulatory expectations. Work Schedule and Eligibility Our flexible/ hybrid work schedule includes 3 in-person days at one of our core...Full timeWork at officeLocal areaRemote workFlexible hours$116.86k - $156.05k
At ENFRA, we blend a rich history with a forward-looking vision. With over 100 years of experience, we are a pillar of stability in the energy infrastructure industry and a leader in innovative energy solutions. Our commitment to leveraging emerging technologies ensures...Contract workFor subcontractorWork at office$40k - $75.6k
.... Help us help others, and join Team Unum today! GENERAL SUMMARY: Our Law Department is seeking a Legal Operations Specialist position to provide dedicated support for critical legal operations processes and address increasing operational demands. The role...Full timeTemporary workWork at officeWorldwideFlexible hours$55k - $65k
Schedule: Full-Time Salary Range: USD $55000.00 - $65000.00 Job Category: Sales - Comparion Description Comparion Insurance Agency is hiring self-motivated, relationship-driven professionals for a rewarding outside sales career. This role offers autonomy and flexibility...Full timeWork at officeLocal areaRemote workFlexible hoursComparion Insurance Agency
South Portland, ME6 days ago- ...development, FTE management, expense control, policy and procedure development and implementation, and process development to ensure regulatory compliance. Five years of management experience in the healthcare industry, with a minimum of 2‑3 years in a Senior Management...Full timePart timeWork experience placementFlexible hoursNight shiftWeekend workDay shiftAfternoon shiftWeekday work
Encompass Health Corporation
Portland, ME2 days ago - Description The Doubletree & Tru hotels Portland are seeking an experienced and strategic Director of Finance to join our leadership team. Managed by StepStone Hospitality , this role is vital in overseeing, directing, and administering all financial operations of both ...Temporary workLocal area
$120k - $150k
Senior Project Manager Join our Commercial Construction team and take the lead on some of Maine's most visible and complex projects across housing, healthcare, higher education, hospitality, and beyond. As a Senior Project Manager, you'll own project outcomes from...Contract workFor subcontractorWright-Ryan Construction
Portland, ME3 days ago- Benefits: Bonus based on performance Flexible schedule Free food & snacks Opportunity for advancement Paid time off Training & development Competitive salary Benefits/Perks Competitive Compensation Paid Time Off Career Growth ...Full timeSecond jobWork at officeFlexible hours
American Building Group
Portland, ME14 hours ago - MaineHealth is seeking a Medical Director and Division Chief of Dermatology to lead the dermatology program in Portland, Maine. This integrated leadership role provides academic, clinical and administrative oversight for dermatology services across the health system and...Local areaRelocation package
$276.81k - $296.13k
MaineHealth is seeking an experienced and visionary physician leader to serve as Program Director of the MaineHealth Family Medicine Residency Program in Portland, Maine. This is an outstanding opportunity to lead one of New England's most respected Family Medicine...Local areaImmediate startRelocation package- .... Computer literacy and the ability to function in an electronic communication environment are essential. A working knowledge of regulatory compliance requirements is necessary. A commitment to comply with and support safety standards, as well as, all regulatory and company...
Diesel Direct Inc
South Portland, ME14 hours ago - About the Role: Join Maine Windows and Doors, LLC and Maine Luxury Bath Systems, LLC as a Project Manager and play a pivotal role in delivering exceptional home improvement projects. We are looking for a dynamic leader who thrives in a fast-paced environment and is ...For contractorsFor subcontractor
Maine Windows and Doors, LLC
Portland, ME14 hours ago - ...generating programs and external partnerships that expand the Colleges reach and impact. In close collaboration with Advancement, Academic Affairs, Marketing, and other College departments, the role will help shape a cohesive ecosystem of lifelong learning opportunities that...Temporary workWork at officeLocal areaFlexible hoursWeekend workAfternoon shift
MAINE COLLEGE OF ART & DESIGN
Peaks Island, ME1 day ago - CES, Inc. is seeking a Structural Project Manager in Portland, ME. This role involves planning, organizing, and controlling project activities within budget and schedule constraints. The Project Manager will oversee and manage proposal developments, supervise engineering...Relocation package
Haley and Ward Inc
Portland, ME4 days ago $98.03k - $126.57k
Structural Project Manager Are you searching for a new opportunity to join a growing 100% employee-owned company that offers professional development opportunities, values an excellent work life balance and giving back to your community? Are you looking to be the next...Temporary workWork experience placementWork at officeRelocationRelocation packageFlexible hoursHaley Ward, Inc.
Portland, ME4 days ago$90k - $130k
Overview ABOUT THE POSITION Geomatics/Survey Project Manager | Hybrid | Maine Are you an experienced Geomatics professional ready to elevate your career? VHB's dynamic Geomatics team is seeking a talented Geomatics/ Survey Project Manager to join our vibrant...Work at officeLocal areaRemote workFlexible hoursVHB
South Portland, ME1 day ago$95k - $160k
Civil Project Manager Wright-Pierce, an award-winning, multi-discipline environmental engineering firm specializing in water, wastewater and civil infrastructure, is seeking a licensed Civil Project Manager to join our company. Candidates will have experience in engineering...H1bWork at officeLocal areaFlexible hoursWright-Pierce
Portland, ME4 days ago- Project Manager - Water Treatment PC is seeking a motivated self-starter to manage exciting water and wastewater treatment projects throughout the Northeast regions including Vermont, New Hampshire, and Maine. As a PC Project Manager, you will bring enthusiasm and energy...For contractors
PC Construction
Portland, ME3 days ago $113k - $132k
Employment Type: Full-Time FSLA: Salary/Exempt Division: Project Management Department: Project Management Reports to: Project Executive Supervisory Duties: Yes Salary Range: $113,000 - $132,000 The Project Manager (PM) will serve...Full timeFor contractorsFor subcontractorConsigli
Portland, ME2 days ago$120.97k
...expertise with support from the engineering team. • Effectively working with lead practitioners, quality managers, and key technical specialists. For more information about our Project Management roles, tools and culture, please visit this website . Qualifications...Work experience placementH1bCDM Smith
Portland, ME2 days ago
Do you want to receive more vacancies?
Subscribe and receive similar vacancies to Regulatory Affairs Specialist. Be the first to apply!
Related searches
- regulatory South Portland, ME
- compliance South Portland, ME
- compliance lead South Portland, ME
- regulatory affairs South Portland, ME
- housing compliance South Portland, ME
- compliance technician South Portland, ME
- compliance team leader South Portland, ME
- regulatory compliance South Portland, ME
- customs compliance South Portland, ME
- regulatory affairs assistant South Portland, ME