Regulatory Affairs Professional for Medical Devices
Vor 5 Tagen
Aristo Group is a project and personnel consulting company specializing in the Life Science sector. Our goal is to find the 'perfect match' for our customers and candidates.
We are currently looking for a Regulatory Affairs Specialist (m/w/d) for the Hannover area.
Responsibilities:
Execute and assist with medical device registration for EMEA and China
Assist with internal regulatory review processes for product life cycle and product development to ensure conformity assessment according to MDR
Implement and improve internal records systems, particularly regulatory files (Technical File according to MDR Annex II & III or STED)
Support Post-Market Surveillance (PMS) activities according to MDR
Develop, review, and implement Standard Operating Procedures (SOPs)
Evaluate regulatory history, guidelines, policies, and regulations specific to products and markets
Support the evaluation of regulatory impact on current and new products
Contribute to the development of regulatory strategies and updates based on regulatory changes
Communicate effectively with customers and regulatory bodies
Qualifications:
Bachelor's degree (BS) in Engineering, Physics, Chemistry, Biology, or a related field
At least 3 years of experience in medical devices
Knowledge of applicable international regulations and standards, including MDD and/or MDR, ISO 13485, MEDDEV 2.12/1, and Medical Device Coordination Group (MDCG)
The estimated salary for this position is approximately €50,000 - €70,000 per year, depending on qualifications and experience. The Aristo Group offers a dynamic work environment and opportunities for professional growth.
The ideal candidate will have excellent communication skills, be proactive, and possess a strong understanding of regulatory requirements for medical devices. If you are motivated and eager to contribute to a fast-paced team, please apply for this exciting opportunity
-
Hannover, Niedersachsen, Deutschland Aristo Group VollzeitThe Aristo Group is a project and personnel consulting firm specializing in the life sciences industry. We are currently seeking a highly skilled Global Regulatory Affairs Expert for Medical Devices to join our team in Hannover, Germany.About the RoleThis exciting opportunity involves executing and assisting with medical device registration for the European...
-
Regulatory Affairs Specialist
vor 1 Woche
Hannover, Niedersachsen, Deutschland Aristo Group VollzeitMedical Device Regulatory Affairs SpecialistAristo Group is a leading project and personnel consulting firm specializing in the life science industry. Our mission is to find the perfect match for our clients and candidates.We are currently seeking a highly skilled Regulatory Affairs Specialist (m/w/d) for our office in Hannover, Germany.About the JobThe...
-
Hannover, Niedersachsen, Deutschland Aristo Group VollzeitJob OverviewWe are seeking an experienced Regulatory Affairs Specialist to join our team at The Aristo Group in Hannover. This role will be responsible for ensuring regulatory compliance across various regions, including EMEA and China.About the RoleThe successful candidate will execute and assist with medical device registration, internal regulatory...
-
Medical Science Liaison for Transcatheter Therapies
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Edwards Lifesciences VollzeitInnovative Medical SolutionsEdwards Lifesciences, a global leader in patient-focused medical innovations, is seeking an experienced Medical Science Liaison to join our team. This exciting opportunity will allow you to drive and develop groundbreaking medical innovations for structural heart disease and critical care.As a Medical Science Liaison, your primary...
-
Hannover, Niedersachsen, Deutschland Welocalize VollzeitAbout the RoleWe are seeking skilled German linguists to work on translation and editing tasks for Life Sciences projects. As a medical translator, you will be responsible for delivering high-quality translations for our clients in the pharmaceutical and clinical research industries.Key Responsibilities:Translation of Life Sciences contentEditing and...
-
Software Developer for Medical Imaging Solutions
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Sonova VollzeitOverviewSonova, a leader in the hearing industry, is seeking an experienced Software Developer to join our Advanced Bionics Research Center in Hannover. This role will play a crucial part in supporting our implant technology group's mission to develop innovative medical imaging software.Job DescriptionAs a Software Developer, you will be responsible for...
-
Procurement Expert for Strategic Growth
vor 4 Wochen
Hannover, Niedersachsen, Deutschland Hannover Re VollzeitWe are seeking a highly skilled Procurement Expert to join our team at Hannover Re. As a key player in our Procurement & Supplier Management team, you will be responsible for negotiating contracts, conducting tenders, and evaluating offers.Your mission as a Strategic Buyer is to ensure compliance with regulatory requirements while maintaining an efficient...
-
Occupational Health Professional Leader
vor 2 Wochen
Hannover, Niedersachsen, Deutschland ExxonMobil VollzeitCompany OverviewExxonMobil is a global leader in the energy and chemical industry, committed to innovation and excellence in health and safety.We are powered by a diverse workforce that drives our vision for a net-zero future.SalaryThe estimated annual salary for this position is €80,000 - €110,000, depending on experience and qualifications.Job...
-
Talent Acquisition Manager
vor 1 Woche
Hannover, Niedersachsen, Deutschland Workwise VollzeitAbout WorkwiseWorkwise is a dynamic and innovative medical device company that has pioneered a new form of therapy for heart failure called Cardiac Contractility Modulation. Our company is dedicated to delivering life-changing treatments for patients worldwide.
-
Hannover, Niedersachsen, Deutschland voraus robotik VollzeitAbout voraus robotikWe're a pioneer in industrial automation, revolutionizing the way companies work. Our software platform enables efficient and sustainable production systems.Salary and BenefitsThe salary for this position is estimated at €45,000 - €60,000 per year, depending on experience. We offer flexibility in working hours and models, as well as...
-
Hannover, Niedersachsen, Deutschland Eco Plus Solutions AB VollzeitAbout the RoleWe are seeking an experienced Senior Digital Marketing Professional to join our team in Barcelona, focusing on the German-speaking market.Job DescriptionThis position involves serving as the primary point of contact for our German-speaking clients, providing expert guidance on Google Ads and related services. The ideal candidate will have a...
-
Hannover, Niedersachsen, Deutschland Linglong Germany GmbH VollzeitAbout Linglong Germany GmbHLinglong, a leading Chinese tire manufacturer with operations in Asia, North America and Europe, is expanding its R&D team in Hannover. The company employs around 18,500 people worldwide and has sales networks in over 170 countries.Job Description:We are seeking a highly skilled Tire Development Engineer to develop qualitative and...
-
Procurement Professional
vor 3 Wochen
Hannover, Niedersachsen, Deutschland Hannover Re VollzeitWe are looking for a highly skilled Procurement Professional to join our team at Hannover Re. In this role, you will be responsible for negotiating contracts and managing supplier relationships.
-
Aviation Professional Opportunity
vor 3 Wochen
Hannover, Niedersachsen, Deutschland TUI VollzeitAbout the RoleAs a Pilot with TUI, you will be based in one of our 12 UK bases and operate the B737 to various destinations across Europe, North Africa, and other routes.We offer competitive salaries with no training deductions, but you will be bonded. Our pilots enjoy full-time working during the summer and part-time in the winter, with a total of 13 weeks...
-
International Payroll Management Professional
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Hannover Re VollzeitCompany OverviewHannover Re, a renowned reinsurer, offers an exciting opportunity for a skilled International Payroll Management Professional to join their team in Hannover, Germany.
-
Hannover, Niedersachsen, Deutschland Deutsche Bahn Vollzeit**{title}**At {company}, we are looking for {num_employees} exceptional {title} professionals to join our team in {location}.This position offers a unique opportunity to develop expertise in {industry} and work with a talented team.The ideal candidate will have {required_skills} and be passionate about {industry}.To succeed in this role, you will need to...
-
Pharmaceutical Field Service Manager
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Inizio Engage VollzeitRegional Business ManagerBecome part of the Inizio Engage team.We are a global engagement partner for leading health and life sciences businesses. Our mission is to improve millions of lives by delivering exceptional services and solutions.We offer a collaborative culture that provides autonomy, care, and support for our employees to excel and make a...
-
Global Battery Technology Expert
vor 4 Wochen
Hannover, Niedersachsen, Deutschland Clarios Inc. VollzeitAbout the Role:Clarios is the global leader in advanced, low-voltage battery technologies for mobility. Our batteries and smart solutions power nearly every type of vehicle and are found in 1 of 3 cars on the road today. With a strong focus on innovation, we bring deep expertise to our Aftermarket and OEM partners, and reliability, safety, and comfort to...
-
Professional HR Transformation Project Coordinator
vor 2 Wochen
Hannover, Niedersachsen, Deutschland Hannover Re VollzeitJob OverviewWe are seeking a skilled Professional HR Transformation Project Coordinator to join our team at Hannover Re. This is an exciting opportunity to work on an international HR transformation project, supporting the global introduction of SAP SuccessFactors.Salary and BenefitsThe salary for this role is estimated to be around 2011 euros gross per...
-
Tax Professional with Expertise in Domestic Taxation
vor 3 Wochen
Hannover, Niedersachsen, Deutschland BDO VollzeitExpertise in Domestic TaxationBDO is a leading professional services firm that values positive relationships with our people and clients. Our professionals provide exceptional service, helping clients with advice and insight they can trust.We are currently seeking an Intermediate or Senior Accountant to join the Domestic Tax team in Hanover. The successful...