Gujarat , Kheda

Regulatory Affairs Manager

Job ID : 100034

Regulatory Affairs Manager

What you will be doing :

  • Ability to solve regulatory queries & compliance matters.
  • Understanding & knowledge of standards of various international regulatory bodies Updating of relevant SOPs and to conduct training for the same.
  • Keeping abreast with the latest guidelines and regulations.
  • Ensure adherence to deadlines and regulatory compliance.
  • Maintaining databases of regulatory submissions.
  • Filing/Review of Variation applications.
  • Must have knowledge of USFDA audit and previously facing audit of USFDA .
  • Planning, Compilation, review and submission of Documents as per Country Specific regulatory guideline in medical device and coordinating with them for registration.
  • Prepare and maintain technical file and medical device master files as necessary to obtain and sustain product approval.
  • Keeping records to documents and samples of different Countries.
  • Co-Ordination with respective departments for Regulatory requirements such as documents (Quality Analysis report, Comparative study report, Validation protocols and Reports, New product Documents, Samples and Reference Standards etc.)
  • Train staff as and when required on compliance and on other aspects for ISO certifications.
  • Extensive experience in quality assurance and regulatory affairs.
  • International registration & communication with regulatory authorities in different country.
  • In-process audits for compliance to regulations, protocols and SOPs.
  • Manufacturing QA support including thorough review of Batch Manufacturing.
  • Clinical investigation, Risk Management etc.

Essential Requirements :

  • 5-10 yrs experience , B.Pharma / M.Pharma.

Desirable Requirements :

  • Team player who can work with minimum input.
  • Good communication and organizational skills and a meticulous eye for details.
  • Deliver within timelines.

Why Work For US :

  • Miraclus Orthotech Pvt Ltd is an innovative and dynamic company at the forefront of orthopedic technology, providing employees with a unique opportunity to contribute to the advancement of medical science.
  • Joining Miraclus Orthotech means becoming part of a team dedicated to improving the lives of patients by developing cutting-edge orthopedic solutions that enhance mobility, reduce pain, and restore quality of life.
  • We foster a collaborative work environment that encourages creativity, critical thinking, and teamwork, empowering employees to make meaningful contributions and drive positive change.
  • At Miraclus Orthotech, we invest in the professional growth and development of our employees, providing ample opportunities for skill enhancement, training, and career advancement.
  • As a leader in the orthopedic industry, we offer a diverse range of projects and challenges, ensuring that every day brings new opportunities to learn, innovate, and excel.
  • We prioritize work-life balance and employee well-being, offering flexible work arrangements, comprehensive benefits packages, and a supportive culture that values mental and physical health.
  • Miraclus Orthotech values diversity and inclusivity, fostering an environment that celebrates different perspectives, experiences, and backgrounds, making it an enriching and fulfilling place to work.
  • We are committed to maintaining the highest standards of ethics, integrity, and patient safety, providing our employees with a strong sense of purpose and pride in the work they do.
  • Joining Miraclus Orthotech means being part of a global network of professionals, collaborating with experts and thought leaders in the field of orthopedics to drive innovation and make a lasting impact.
  • Our company culture promotes open communication, transparency, and a shared passion for making a difference, creating a supportive and engaging work environment that inspires employees to thrive.

What you'll achieve :

  • By joining Miraclus Orthotech, you will have the opportunity to make a tangible impact on the lives of patients worldwide, contributing to the development of innovative orthopedic solutions that improve mobility and enhance quality of life.
  • As a member of our team, you will play a vital role in advancing orthopedic technology, working alongside industry experts and thought leaders to drive innovation and shape the future of orthopedic care.
  • At Miraclus Orthotech, you will have the chance to expand your knowledge and expertise in the field of orthopedics, with access to cutting-edge technologies, training programs, and continuous learning opportunities.
  • You will work in a collaborative and dynamic environment, where your ideas and contributions will be valued and encouraged, allowing you to unlock your full potential and achieve professional growth.
  • As part of our team, you will be involved in multidisciplinary projects and collaborations, collaborating with talented professionals from diverse backgrounds, and fostering a culture of innovation and collaboration.
  • Working at Miraclus Orthotech, you will have the chance to develop and refine your skills through challenging and meaningful projects, contributing to the development of groundbreaking orthopedic solutions that push the boundaries of medical science.
  • You will have the opportunity to work with state-of-the-art facilities and advanced tools, enabling you to carry out your work with precision and efficiency, ensuring the highest quality standards in our products and services.
  • At Miraclus Orthotech, we encourage and support professional growth and career advancement, providing mentorship, leadership opportunities, and a clear path for personal and professional development within the organization.
  • As a valued member of our team, you will have the satisfaction of working in a mission-driven company that prioritizes patient well-being, ethical practices, and the highest standards of quality in all aspects of our work.
  • By working at Miraclus Orthotech, you will be part of a global network of professionals, collaborating with experts from around the world and expanding your professional network, opening doors to future opportunities and career growth.

Who We Are :

  • Miraclus Orthotech Pvt Ltd is a leading orthopedic technology company dedicated to transforming the field of orthopedics through innovative solutions and advanced medical devices.
  • We are a team of passionate professionals, including engineers, researchers, and medical experts, united by a common goal of improving patient outcomes and revolutionizing orthopedic care.
  • With a strong focus on research and development, we leverage cutting-edge technologies and scientific advancements to create state-of-the-art orthopedic implants and surgical instruments.
  • Miraclus Orthotech takes pride in its commitment to excellence, upholding the highest quality standards in our products, and prioritizing patient safety and satisfaction.
  • As an organization, we strive to make a positive impact in the global healthcare community by delivering reliable, innovative, and patient-centric orthopedic solutions that address the unique needs of individuals around the world.

Salary Range : Btw 5-10 LPA

Apply Now