Company Description Biotek Ortho is a global medical device company specializing in new product development in the advanced orthopedic sector of SPORTS MEDICINE. With a presence on all six continents, Biotek remains committed to delivering uncompromising quality to healthcare professionals and impacting the lives of millions of patients worldwide. Mission Statement: Empowering Clinicians, Redefining Mobility, Transforming Lives. Role Description This is a full-time on-site role for an Area Sales Manager at Biotek Ortho in Ahmedabad. The Area Sales Manager will be responsible for managing and growing sales within Gujarat & Madhya Pradesh, developing and executing sales strategies, building and maintaining customer relationships, and achieving sales targets. Qualifications Experience in the medical device manufacturing or ortho industry is a mandatory Experience in sports medicine company would be given priority Sales and Marketing skills Experience in developing sales strategies and achieving sales targets Excellent communication and negotiation skills Customer relationship management skills Ability to analyze market trends and provide feedback Strong organizational and time management skills Show more Show less
As an Inside Sales Coordinator- Export at Biotek, your role involves managing customer inquiries, processing orders, preparing export documents, and ensuring customer satisfaction. You will need to provide exceptional customer service, maintain communication with clients, and support the sales team in achieving their targets. Key Responsibilities: - Manage customer inquiries effectively - Process orders accurately and in a timely manner - Prepare export documents following the necessary guidelines - Coordinate with other departments to ensure seamless customer experience Qualifications Required: - Skills in Inside Sales, Order Processing, and export documentation - Proficiency in Customer Service and Customer Satisfaction - Strong Communication skills - Ability to work independently and collaborate with teams - Experience in the medical device or healthcare industry would be advantageous - Bachelor's degree in Business, Marketing, or a related field Join Biotek, a global medical device company dedicated to impacting millions of patients" lives through innovation and growth. Embrace the opportunity to contribute to the advancement of orthopedic sectors like sports medicine while delivering clinical and economical value to surgeons and patients.,
Company Description Biotek Ortho is a global medical device company specializing in cutting-edge innovation within the orthopedic sector, particularly in sports medicine and extremities. With a strong presence across six continents, Biotek continues to experience robust growth and demand for its high-quality products. Despite its global reach, Biotek remains a privately held company with a family-oriented business culture, committed to providing exceptional value and improving patient outcomes. Guided by its mission to deliver clinical and economic value to surgeons and patients, Biotek is dedicated to advancing healthcare through its innovative solutions. Key Responsibilities: · Understanding of International country specific New Product Registration requirements, Renewals, labelling requirements, Tender submission requirements and create dossiers that are compliant with regional regulations. · Responsible for identifying and addressing gaps in product/process/labelling compliance, and work through the non-conformity assessment and pushing the analysis further to CAPA. · Communicate and coordinate with distributors and regulatory consultants for country registration and providing relevant documents and letters by collaborating with other stakeholders. · Complete Gap analysis of labelling and packaging input documents in compliance with EU MDR and 21CFR820 and create an action plan to implement the identified gaps. · Provide technical support by interpreting regulations as they apply to products, processes, practices, and procedures and communicate to superior and cross functional teams. · Ensuring compliance for existing certified products, and upcoming new products throughout product life cycle. · Maintain regulatory register, product list, Declaration of conformity and list of standards upto date. · Identification and implementation of the Change through change control management process. · Co-Ordination with respective departments for different Regulatory documents and preparation of documents. · Perform other related functions and responsibilities as directed by seniors & Manager. Essential Skills: · Well versed with GSPR, ICH guidelines and QSR. · Detailed Knowledge and Hands on experience of Dossier preparation compliant with ISO 13485, ISO 14971, ISO 20417, ISO 11607, ISO 15223, EU MDR 2017, FDA 21 CFR and CDSCO guidelines for Orthopedic medical devices. · Regulatory submission requirement knowledge in different regions not limited to APAC, CEMA, EMEA, MEA, LATAM, EU, US FDA is a plus. · Well acquainted with Microsoft office and SharePoint. · Excellent written and verbal communication skills in English language is must.
BIOTEK is a global medical device company focusing on new product development in the most advanced Orthopaedic sector: SPORTS MEDICINE. With presence on all six continents worldwide, the growth and demand for our products around the globe is unprecedented. As a Regulatory Affairs Sr. Coordinator, you'll play a crucial role in regulatory submissions for Orthopaedic implants and instruments in regulated, semi-regulated, and domestic markets and will be key point of contact in resolving the Regulatory related product queries coming from cross functional internal and external teams. Experience: 2 to 4 years Key Responsibilities: · Understanding of International country specific New Product Registration requirements, Renewals, labelling requirements, Tender submission requirements and create dossiers that are compliant with regional regulations. · Responsible for identifying and addressing gaps in product/process/labelling compliance, and work through the non-conformity assessment and pushing the analysis further to CAPA. · Communicate and coordinate with distributors and regulatory consultants for country registration and providing relevant documents and letters by collaborating with other stakeholders. · Complete Gap analysis of labelling and packaging input documents in compliance with EU MDR and 21CFR820 and create an action plan to implement the identified gaps. · Provide technical support by interpreting regulations as they apply to products, processes, practices, and procedures and communicate to superior and cross functional teams. · Ensuring compliance for existing certified products, and upcoming new products throughout product life cycle. · Maintain regulatory register, product list, Declaration of conformity and list of standards upto date. · Identification and implementation of the Change through change control management process. · Co-Ordination with respective departments for different Regulatory documents and preparation of documents. · Perform other related functions and responsibilities as directed by seniors & Manager. Essential Skills: · Well versed with GSPR, ICH guidelines and QSR. · Detailed Knowledge and Hands on experience of Dossier preparation compliant with ISO 13485, ISO 14971, ISO 20417, ISO 11607, ISO 15223, EU MDR 2017, FDA 21 CFR and CDSCO guidelines for Orthopedic medical devices. · Regulatory submission requirement knowledge in different regions not limited to APAC, CEMA, EMEA, MEA, LATAM, EU, US FDA is a plus. · Well acquainted with Microsoft office and SharePoint. · Excellent written and verbal communication skills in English language is must. Educational Background: Bachelor's in pharmacy or Master's in pharmacy or MS. in Medical device Regulatory Affairs domain with atleast 2 years of medical device industry experience is must
Role Overview: As an Inside Sales Coordinator- Export at Biotek, located in Sanand, you will be responsible for managing customer inquiries, processing orders, preparing export documents, and ensuring customer satisfaction. Your role will involve providing exceptional customer service, maintaining communication with clients, and supporting the sales team in achieving their targets. Key Responsibilities: - Managing customer inquiries and providing timely and accurate responses - Processing orders efficiently and accurately - Preparing export documents in compliance with regulations - Coordinating with other departments to ensure smooth order processing and delivery - Maintaining communication with clients to address any issues or concerns - Supporting the sales team in achieving their targets Qualifications: - Skills in Inside Sales, Order Processing, and export documentation - Proficiency in Customer Service and ensuring Customer Satisfaction - Strong Communication skills - Ability to work independently and coordinate effectively with teams - Experience in the medical device or healthcare industry is a plus - Bachelor's degree in Business, Marketing, or a related field is required.,