Senior Associate - Regulatory Affairs (Reg Ops EU MDR) at ClinChoice

Bengaluru, karnataka, India -

Full Time

Start Date

Immediate

Expiry Date

05 May, 26

Salary

0.0

Posted On

04 Feb, 26

Experience

5 year(s) or above

Remote Job

Yes

Telecommute

Yes

Sponsor Visa

Skills

Regulatory Affairs, EU MDR, Regulatory Operations, ISO 13485, FDA Regulations, Microsoft Office, Communication Skills, Quality Control, Project Management, Document Management, Cross-Functional Collaboration, Regulatory Compliance, Data Analysis, Clinical Trials, Health Authority Interaction, Team Collaboration

Industry

Pharmaceutical Manufacturing

Description

Job Title: Senior Associate - Regulatory Affairs (Reg Ops EU MDR) Employment Type: Full time Location: Bengaluru, India Work type: Remote Experience: 4 to 6 Years About ClinChoice ClinChoice is a partner to the largest pharmaceutical, medical device, and consumer care innovators in the world. Established in 1995, we provide expertise in clinical operations, biometrics, regulatory affairs, pharmacovigilance, medical affairs, and toxicology to help our partners advance healthcare by accelerating clinical trials with data-driven insights, delivering the best strategies for product registration, and enhancing patient safety through real-world and clinical analysis. Our global delivery network has expanded to centers and satellite offices in the United States, Mexico, the United Kingdom, Armenia, China, Japan, India, and the Philippines to help our customers maintain regulatory compliance locally and globally. We have forged future-defining partnerships with industry bodies and technology companies to develop cutting-edge solutions that deliver our expertise with quality and precision. Responsibilities: • Actively collaborate with the client’s regulatory project team to identify and collect all necessary TF/DD documents in compliance with EU MDR (2017/745) and related guidance (MDCGs) for maintenance and resubmission. The high-level activities may include, but are not limited to: ▪ Identify applicable regulatory requirements, harmonized standards, guidance documents, and submission expectations. ▪ Review, obtain, and combine TF/DD documents in PLM or similar regulatory sources into Adobe PDF files. ▪ Create and upload bookmarks/indexes of the Adobe PDF files into PLM via Change Orders. ▪ Perform Quality Control checks in accordance with client procedures, training, and checklists, including verification of completeness, correct pagination, and absence of blank or missing pages. • Work with cross-functional teams and affiliates to obtain necessary legal documents (e.g., Certificate to Foreign Government (CFG), Certificate of Free Sale (CFS), and/or supporting documents from projects). • Respond to inquiries from the Company’s local affiliates and proactively notify and coordinate with cross-functional teams, including management, or on any health authority-related questions or requests. • Represent Regulatory Affairs on project teams and report regulatory requirements in the frequency, format, and sequence as required. • Attend meetings and communicate with the project team as appropriate. • Routinely communicate with the regulatory management team regarding project status and deliverables. • Support other regulatory activities as assigned. Minimum Requirements: • Bachelor’s degree (life sciences preferred). • Minimum of 4–6 years of working experience in Regulatory Affairs focused on EU MDR and Regulatory Operations. • Knowledge of EU MDR, ISO 13485, and FDA medical device regulations is mandatory. • Working proficiency in Microsoft Office (e.g., Word, Excel, PowerPoint). • Strong written and verbal English communication skills required.

Responsibilities

The Senior Associate will collaborate with the client’s regulatory project team to ensure compliance with EU MDR and manage necessary documentation. Responsibilities include quality control checks, obtaining legal documents, and communicating with cross-functional teams.