Regulatory Affairs - Sr. Co-Ordinator

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