Regulatory Affairs Specialist (f/m/d)
At Cantel, preventing infection is our business. As a leading provider of infection prevention products and services in the healthcare market, we are dedicated to delivering high-quality, innovative solutions that improve outcomes and help save lives. We accomplish this mission by delivering our products through the following operating units: Medical: Endoscopy procedure disposables include single-use valves and irrigation tubing. The medical device reprocessing systems, disinfectants, detergents we manufacture and distribute are used to disinfect high-level endoscopes. Life Sciences: Water purification systems for dialysis facilities. We work with leading dialysis caregivers, delivering hemodialysis dialyzers and reprocessing systems, as well as sterilants and filtration products. Dental: Single-use, infection prevention products used primarily in the dental market (face masks, sterilization pouches, towels and bibs, tray covers, saliva ejectors, germicidal wipes, plastic cups and disinfectants). Cantel employees are inspired to improve the lives of patients, caregivers and healthcare providers. If you are looking for a company driven by an entrepreneurial spirit and have the passion to shape the future of infection prevention, we want to meet you. Join us and see why people love working here. Supports all German Cantel entities (Medical Division) in all regulatory matters Responsible and accountable for regulatory affairs and compliance activities in the German market covering all company product lines brought on the market or to be launched by Cantel Germany or CPG. Responsible for pre-market and post market local monitoring, and reviewing regulatory requirements, including but not limited, o Medical Device Law for Germany, o All relevant EU directives and regulations, including Medical Device Directive, Medical Device Regulations, REACH and Personal Protection Regulations o RKI guidelines or instructions by BfArM and other relevant Competent Authorities Ensuring that German Management and Regulatory Management EMEA are fully appraised of RA requirements and activities for the German market. Assist in the determination of regulatory pathways and requirements for new and revised products and project teams within Cantel Germany and throughout the wider company. Plan, develop, prepare and submit regulatory submissions to appropriate agencies in both domestic German and if applicable international markets with primary focus with on the Cantel Germany business and a supporting focus on other German activities. Supports and improves the Cantel EMEA regulatory compliance position by completing regulatory affairs tasks to help achieve RA departmental and overall business objectives, particularly relating to Cantel and CPG (or it’s successive name) activities Facilitate achievement of Cantel overall and in particular German business objectives, while ensuring compliant operation within the flexibility of the regulations. Coordinate Cantel Germany and CPG vigilance and post-market surveillance activities together with Global teams, and serve, if necessary and applicable, as the formal designated secondary safety officer (Regulatory Compliance Officer) for Cantel Germany business. Bachelor/ master’s degree completed in Germany in regulatory affairs, scientific, engineering or technical discipline 2-3 years of professional experience in regulatory affairs in medical engineering/ technology, preferably in medical devices, or equivalent, International Experience preferable Profound knowledge of international regulations in the areas of the medical devices/technology, ISO 13485 and EU MDD/MDR/PPER/REACH Profound knowledge of local regulatory and legal requirements (MPG, local guidelines e.g. published by RKI, DQS, BfArM etc) Experience in microbiology, medical hygiene, sterilization/disinfection and device reprocessing preferred Proof of strong written and verbal communication skills, especially when dealing with governmental agencies German mother tongue; fluent in English Ability to explain and resolve differences in regulations Experience in planning and preparing international regulatory submissions is required General computer knowledge and experience using Microsoft Office software Willingness to travel •Long-term and permanent position in an expanding company with a future • Varied and exciting jobs in a rapidly growing company tasks • A full-time job with a high degree of personal responsibility, design and development opportunities • Short decision paths • Good earning potential • Appreciative and open corporate culture • Free drinks beverages
Senior Projektmanager (m/w/d) Device Development • Combination Products • Biosimilars • Home-Office Option
Neuendorf B, Augsburg, Nürnberg, Regensburg
Ihre Herausforderung! Neue Technologien in Bio- und MedTech Kompetenter Projektmanager/in als Senior Projectmanager Device Development Combination Products • Biosimilars Medizintechnik & Pharma • Entwicklung und Zulassung Start-up Kultur, agile und innovative Beratungsfirma Bayern z. B. München, Augsburg, Nürnberg, Regensburg • Home Office Option Our Client: As a fast-growing Consultancy Company, we support product development and compliance projects in the European MedTech and Pharma/Biotech Industry. In particular, we help new entrants into the exploding Biosimilars market to enable the success of their medical device and combination products. Due to the increased number of projects and the changing requirements for the approval and registration of medical devices, we would like to strengthen our team and gain a qualified personality with your profile for this newly created position. After a focused induction period, you will quickly assume lead responsibility for newly acquired technical projects. Decisive for your success will be that you display a high level of independence and confidence to provide guidance to our customers on the many aspects of the entire device development process. Flat hierarchies - you report directly to the CTO and Co-Founder - and a high degree of autonomy will facilitate to make an immediate positive impact and have a lasting impressionDo you have a university degree, for example in engineering, industrial engineering or natural and life sciences? Are you acquainted with operations such as MedTech and Pharmaceutical product development? Is independent project management one of your strengths? Ideally, you are familiar with Design Verification, Human Factors as well as risk management for combination products. And are you seeking a new challenge that involves a high level of responsibility and the associated room for manoeuvre in an agile business environment? Then we would like to get to know you!In addition to convincing conditions, Home Office, flexible working hours, company pension scheme and further professional education and training, we offer you a secure job in an international operating, fast-growing and innovative consulting company in the Biosimilars and MedTech Market.