Position Overview
Position Name: Regulatory Affairs Specialist
Organization: Molex
Location: Bangalore, India
Experience Required: 5+ years
Qualification: B.Pharm, M.Pharm, Pharm.D, M.Sc, B.Sc, Lifesciences, M.Tech, B.Tech
Salary: Not disclosed
Molex, a global leader in electronics and medical device solutions, is seeking an experienced Regulatory Affairs Specialist to join our dynamic team in Bangalore, India. This position is crucial in ensuring compliance with regulatory standards for our medical devices. You will play a key role in supporting the design and development of innovative drug delivery devices and connected health solutions.
About Molex and Phillips Medisize
Phillips Medisize, a part of Molex, is at the forefront of designing and delivering advanced drug delivery devices and connected health solutions. Our clientele includes leading pharmaceutical companies worldwide. With the recent establishment of our Global Innovation and Development Center in Bangalore, we are committed to expanding our footprint in the Asian region.
Key Responsibilities
As a Regulatory Affairs Specialist, your role will involve the following key responsibilities:
1. Regulatory Strategy and Compliance
- Develop Regulatory Submission Strategy: Participate in the formulation of regulatory submission and approval strategies across multiple countries.
- Maintain Regulatory Awareness: Keep abreast of new and existing regulatory requirements, ensuring that all processes comply with industry standards.
- Interpret Regulatory Requirements: Assist in identifying applicable regulatory requirements, evaluating their impact, and providing interpretations for internal teams.
2. Documentation and Submission
- Generate Documentation: Execute regulatory strategies by applying relevant requirements and generating necessary documentation.
- Review Technical Documentation: Ensure all technical documentation complies with regulatory standards.
- Assemble Regulatory Submissions: Compile and support the submission process of regulatory documentation to appropriate authorities.
3. Stakeholder Interaction
- Customer and Regulatory Interaction: Engage with customers and regulatory authorities to secure regulatory approval and clearance.
- Maintain Product Conformity: Continuously update and maintain technical documentation to ensure ongoing product conformity and approval.
4. Cross-Functional Collaboration
- Collaborate with Teams: Work closely with development, risk management, usability, clinical, testing, and manufacturing teams to ensure alignment and regulatory compliance.
Qualifications and Skills
Who You Are (Basic Qualifications)
- Educational Background: Bachelor’s degree or higher in life sciences or engineering.
- Experience: Minimum of 5 years in quality or regulatory roles within the medical device industry.
- Regulatory Knowledge: Strong understanding of Medical Device Regulation (EU) 2017/745, ISO 13485, ISO 14971, and other relevant standards.
- Technical Standards: Familiarity with technical and injector-specific standards, such as ISO 11608.
- Documentation Expertise: Experience in preparing technical documentation for European submissions, 510(k) submissions, Device Master Files (MAF), and foreign registrations.
- Communication Skills: Excellent written and verbal communication skills in English.
What Will Put You Ahead
- Integrity and Empathy: High level of integrity, credibility, and empathy in professional interactions.
- Global Mindset: Ability to work collaboratively across cultures and communicate effectively in a global context.
- Self-Motivation: Results-oriented with strong problem-solving skills and a proactive mindset.
- Commitment: Dedicated to meeting deadlines and maintaining high-quality standards.
- Multitasking: Ability to manage multiple projects and tasks efficiently.
Career Growth and Opportunities
At Molex, we believe in fostering a culture of entrepreneurship and innovation. As a Regulatory Affairs Specialist, you will have the opportunity to:
- Global Collaboration: Work with a global team of highly qualified colleagues based in Bangalore, India.
- Continuous Development: Engage in well-structured training programs and continuous development of your competencies.
- Career Advancement: Explore exciting career possibilities within the rapidly growing field of medical devices.
- Process Setup: Contribute to setting up processes and development teams to support Indian customers.
Compensation and Benefits
Molex offers a competitive salary package and a range of benefits that reflect our commitment to our employees’ well-being. The actual salary may vary depending on your experience, skills, and geographic location.
About Koch Industries
Molex is a subsidiary of Koch Industries, a diverse group of companies that value integrity, entrepreneurship, and collaboration. At Koch, we challenge the status quo, encourage innovation, and reward individual contributions.
Apply Now
If you are a dedicated professional with a passion for regulatory affairs and medical device innovation, we invite you to apply for this exciting opportunity.
For more information on how to apply, please visit https://pharmajobscare.com.
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