Do you want to work in an environment and culture where you can thrive, develop and advance?
A career with Kinapse means your everyday work improves patients’ lives around the world. We are a values driven company with a supportive and flexible culture. You will work in a collaborative environment with team members who share their expertise and knowledge. Your personal and professional development will be front and center. We can offer you a fulfilling and challenging career working with smart, yet humble professionals. We reward and recognize our people by providing valuable benefits and a quality of life balance.
An opportunity has arisen for a Senior Consultant (CMC Regulatory Affairs) to be based in Gurgaon or Bangalore.
1. Project Delivery
- Plan, review and compilation of technical documentation and design dossiers in support of CE marking, 510(k), or other approval procedures for device products for global markets.
- Ensure that country specific regulatory requirements are fulfilled, including authoring and review of summary technical information, Essential Principles checklists, lists and evidence for applicable international standards or guidance documents, ensure source documents obtained from third parties and other requirements as applicable to specific product families.
- Proactively identifies moderately complex issues and risks to project delivery in own work or work of the team and escalates appropriately with associated resolution proposals
- Liaise proactively with the functions including stakeholders from R&D, Marketing, Quality and Operations and participate as a member of a cross-functional team for providing regulatory advice
- May support the Manager or Senior Manager in delivery and/or the successful initiation, execution and completion of regulatory services for Kinapse’ Global clients
- Should be well acquainted with the medical device regulatory requirements and changing device regulations.
Author regulatory documents which meet agreed quality standard as agreed with client within stipulated time and cost.2. Problem Solving and Analysis
- Exhibits a growing awareness of project strategy and thinking capability alongside independence
Reviews and provides solutions for issues relating to project delivery or escalates appropriately to the Team Leader/Program Leader/Program Director as required 3. People Development
- May be involved in people development in partnership with PDG leads
Provide training and mentoring of team members depending upon the project requirement
4. Training Compliance
- Ensure that all training (Kinapse internal training and client training) are successfully completed in a timely manner
- Post Graduate with Masters in Pharmacy / Masters in Engineering
- Experience in device regulatory filings as a part of a pharmaceutical or medical device company is required
- Experience in supporting Quality system activities including Internal Audit and change control activities is preferred.
- Good knowledge of strategy development and implementation techniques for Medical Device registrations and technical knowledge of medical device products.
- Working knowledge of Medical device Regulations (including IMDRF, EUMDR, FDA) and exposure to relevant document management systems are preferred
- Good oral / written communication skills
- Working knowledge of basic office applications, e.g. MS Word/ PowerPoint/ Excel, will be required.
We believe that Diversity & Inclusion are central to a dynamic, exciting and innovative organization. To review our D&I policy please visit https://kinapse.com/diversity-inclusion