
Medical Device Compliance Expert
6 days ago
Job Summary
We are seeking a highly skilled Regulatory Affairs Manager to join our team. This individual will be responsible for analysing regulatory requirements, connecting them to product documentation, and ensuring that our products conform to local regulations.
Responsibilities
- Key Responsibilities:
- Analyse regulatory requirements and connect them to product documentation to ensure compliance.
- Work closely with cross-functional teams to identify regulatory pathways and translate them into requirements to enable product registration in prioritized markets.
- Plan and prepare technical documentation and submission dossiers for FDA and expedite approval of pending applications.
- Monitor and interpret regulations, standards, and guidelines and communicate their impact.
- Conduct regulatory actions such as pre-submission, dossier preparation, license renewals, change notifications, etc., to enable successful product launch and product license maintenance.
Qualifications
- A university degree and regulatory affairs experience within the medical device or in-vitro diagnostics industries.
- Ability to articulate regulatory requirements translated into business impact and opportunities.
- Experience in working within an IVD/Medical Device environment (EU IVDR, ISO 13495).
- Experience in preparation of regulatory documentation including pre-submissions, 510(k)s, CE-IVDR technical documentation, etc.
- Knowledge of specific considerations related to software and cybersecurity in a regulatory context.
- Excellent written and verbal communication skills in English.
-
Project Lead
11 hours ago
Uppsala, Uppsala, Sweden Nordberg Medical Full timeJob Description:Nordberg Medical, a leading innovator in the medical device industry, is seeking a highly motivated and experienced Project Manager to join our dynamic team.Key Responsibilities:Lead cross-functional teams to deliver complex projects on time, within scope, and in compliance with regulatory standards.Develop detailed project plans, timelines,...
-
Compliance and Risk Director
2 days ago
Uppsala, Uppsala, Sweden Antaros Medical Full timeAbout UsAt Antaros Medical AB, we combine cutting-edge imaging with extensive experience in drug development and deep knowledge of disease mechanisms. Our goal is to deliver innovative solutions that make a real difference in patient lives.Our TeamWe are a dynamic and collaborative team of experts dedicated to advancing medical research. We believe in...
-
Medical Devices Territory Sales Professional
4 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeAbout the RoleMEDICAL DEVICES TERRITORY SALES PROFESSIONAL:This role involves developing strategic approaches to optimize customer service, acquiring new customers through technical expertise, and implementing marketing and sales strategies in the sales process.The successful candidate will be responsible for conducting negotiations with surgeons, hospital...
-
QA Director to Antaros Medical
3 weeks ago
Uppsala, Uppsala, Sweden Antaros Medical AB Full timeWould you like to work as a QADirectorin a growing company devoted to makinga real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere?Ifthiscatches your interest, you should continue reading.At Antaros Medical, we are pioneering imaging...
-
QA Director to Antaros Medical
3 weeks ago
Uppsala, Uppsala, Sweden Antaros Medical AB Full timeWould you like to work as a QADirectorin a growing company devoted to makinga real difference in drug development through ground-breaking imaging? A place that is constantly moving forward, with great science, great people, and an informal atmosphere?Ifthiscatches your interest, you should continue reading.At Antaros Medical, we are pioneering imaging...
-
Regulatory Compliance Manager
6 days ago
Uppsala, Uppsala, Sweden Rarity Bioscience Full timeQuality ExpertiseWe are seeking an experienced Quality Specialist to join our team at Rarity Bioscience. As a key member, you will be responsible for ensuring the highest standards of quality and regulatory compliance across our operations.Key ResponsibilitiesQuality Management System: Implement and maintain our ISO 13485 quality management system to ensure...
-
Device Control Process Lead
4 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeWe are seeking a highly skilled professional to fill the role of Device Control Process Lead at our Uppsala site. As a key member of our team, you will play a pivotal role in ensuring regulatory compliance and driving consistency across medical device development projects.Key ResponsibilitiesDevelop and implement a robust design control process that adheres...
-
MS&T Leader for Device Injectables
22 hours ago
Uppsala, Uppsala, Sweden SallyQ AB Full timeAbout the RoleWe are seeking a highly skilled and experienced leader to join our Manufacture, Science and Technology (MS&T) department. As a Manager for Device Injectables, you will be responsible for implementing plans and programs to support new product manufacturing, ensuring smooth transition of products from R&D into full production readiness.You will...
-
Regulatory Compliance Expert
5 days ago
Uppsala, Uppsala, Sweden Nordberg Medical Full timeAbout the RoleWe are looking for an experienced Quality Assurance Specialist to lead our efforts in ensuring the quality and compliance of our manufacturing processes. As a key member of our QA team, you will be responsible for reviewing batch records, investigating deviations, and implementing corrective actions to maintain our high standards.This is a...
-
Regulatory Compliance Expert
6 days ago
Uppsala, Uppsala, Sweden Rarity Bioscience Full timeRarity Bioscience OverviewWe are a dynamic and innovative company with a strong focus on research and development.Our products are based on superRCA technology, which offers ultra-high sensitivity detection of multiple mutation targets simultaneously in liquid biopsies.Job DescriptionAs a Verification Specialist, you will be responsible for leading...
-
Medical Sales Professional
2 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeWe are seeking a highly motivated and results-driven Medical Sales Professional to join our team in Uppland, Dalarna, GÄvleborg & North Stockholm regions. As a Territory Sales Manager, you will play a key role in promoting and selling Stryker's Joint Replacement product portfolio, supporting the sales cycle of innovative Mako Robotics.About the Job:Develop...
-
Device Injectables Operations Manager
5 days ago
Uppsala, Uppsala, Sweden SallyQ AB Full timeSallyQ AB is a renowned consulting firm dedicated to delivering high-quality services to clients across various industries. Our team of experts has extensive experience in helping companies achieve their strategic goals, and we're now seeking talented professionals to join our ranks.About the PositionWe're currently recruiting two senior consultants to join...
-
Quality Assurance Specialist
5 days ago
Uppsala, Uppsala, Sweden Nordberg Medical Full timeCompany OverviewNordberg Medical is a leading provider of innovative medical solutions, committed to delivering high-quality products that meet the evolving needs of patients and healthcare professionals.We are seeking a highly skilled Quality Assurance Specialist to join our team in Stockholm. This role will play a critical part in ensuring the quality and...
-
Territory Sales and Product Specialist
4 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeAbout the JobTerritory Sales and Product Specialist - Medical Implants:This role involves developing strategic approaches to optimize customer service, acquiring new customers through technical expertise, and implementing marketing and sales strategies in the sales process.The successful candidate will be responsible for conducting negotiations with...
-
Director of Quality Assurance
2 days ago
Uppsala, Uppsala, Sweden Antaros Medical Full timeAbout the RoleWe are seeking a highly skilled Director of Quality Assurance to join our team at Antaros Medical AB. The successful candidate will be responsible for managing quality activities within our organization, ensuring compliance with regulatory requirements, and maintaining our high-quality standards.Key ResponsibilitiesDevelop and maintain quality...
-
Payroll Compliance Expert
4 days ago
Uppsala, Uppsala, Sweden TN Sweden Full timeWe are seeking a highly skilled and experienced payroll compliance expert to join our team at TN Sweden. As a key member of our Global Payroll Audit function, you will play a critical role in ensuring the accuracy and compliance of payroll operations across multiple countries.The ideal candidate will possess extensive experience in payroll compliance, audit,...
-
Magnetic Resonance Imaging Expert
4 days ago
Uppsala, Uppsala, Sweden Antaros Medical Full timeJoin Our TeamAs an Imaging Director at Antaros Medical, you'll contribute to groundbreaking imaging projects that advance medical understanding and improve lives.With a strong foundation in Magnetic Resonance Imaging and a proven track record in leadership roles, you'll guide our team in delivering high-quality results and driving business...
-
Senior MS&T Manager Device Injectables
5 days ago
Uppsala, Uppsala, Sweden SallyQ AB Full timeAt Galderma, we're expanding our operations to become the leading dermatology company in the world. As a result, we need experienced leaders who can drive growth and innovation within our Manufacture, Science, and Technology (MS&T) department.The RoleWe're seeking two talented individuals to fill managerial positions within the MS&T department, focusing on...
-
Lean Manufacturing Expert
3 days ago
Uppsala, Uppsala, Sweden The Chemical Engineer Full timeWe are seeking a highly skilled Lean Manufacturing Expert to join our team at The Chemical Engineer. In this role, you will lead process and equipment improvement and development activities, working closely with our engineering team to support operations with technical solutions for components, products, and processes.We are currently undergoing a...
-
Process Excellence Lead
6 days ago
Uppsala, Uppsala, Sweden Rarity Bioscience Full timeAbout This RoleThis Quality Specialist position plays a critical role in upholding our high standards of quality and regulatory compliance at Rarity Bioscience. As a key member of our team, you will be responsible for ensuring the accuracy and efficiency of our quality management system.Your Key ResponsibilitiesQuality Management System: Maintain our ISO...