Regulatory Affairs - Senior Coordinator

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.