Regulatory Affairs Specialist - Contract Role at Koch Inc. · Bengaluru

Your Job

Are you passionate about bringing innovative medical devices and combination products to patients around the world? Phillips-Medisize is looking for a Regulatory Affairs Specialist to support global regulatory submission, approval, and registration activities. In this role, you will work at the intersection of medical device and drug regulations, helping customers successfully navigate complex global regulatory requirements while ensuring compliance throughout the product lifecycle.

Our Team

You will join Phillips-Medisize's growing Global Innovation & Development Center in Bangalore, working within the Regulatory Affairs organization. The team collaborates closely with project teams, customers, and regulatory authorities worldwide to support regulatory strategy, submissions, approvals, and market access for medical devices and combination products.

What You Will Do

• Drive global regulatory strategies that enable successful product registrations and market access.
• Prepare and maintain high-quality regulatory documentation for submissions across multiple countries.
• Partner with project managers, cross-functional teams, customers, and regulatory authorities to support product approvals.
• Review technical documentation to ensure compliance with applicable medical device regulations and standards.
• Support regulatory submissions and market clearance activities throughout the product lifecycle.
• Assess the impact of product and process changes on existing regulatory approvals.
• Contribute to the continuous improvement of regulatory affairs processes and submission practices.
• Help ensure compliance in a rapidly evolving global regulatory environment.

Who You Are (Basic Qualifications)

• Bachelor's degree in Life Sciences, Engineering, or an equivalent discipline.
• Minimum 5 years of Regulatory Affairs experience within the Medical Device industry.
• Knowledge of medical device regulations, standards, and guidance documents in the US, EU, and other global markets.
• Experience preparing technical documentation for regulatory submissions.
• Strong organizational, documentation, and project management skills.
• Ability to work effectively in a multidisciplinary and dynamic environment.
• Excellent written and verbal communication skills in English.
• Proficiency with Microsoft Office applications.

What Will Put You Ahead

• Experience obtaining medical device approvals in the US, EU, and other global markets.
• Experience supporting global regulatory registrations and submissions.
• Experience with Drug-Device Combination Products in the US and EU.
• Ability to quickly learn and adapt to changing regulatory requirements.
• Demonstrated ability to drive regulatory process improvements.

At Koch companies, we are entrepreneurs. This means we openly challenge the status quo, find new ways to create value and get rewarded for our individual contributions. Any compensation range provided for a role is an estimate determined by available market data. The actual amount may be higher or lower than the range provided considering each candidate's knowledge, skills, abilities, and geographic location. If you have questions, please speak to your recruiter about the flexibility and detail of our compensation philosophy.

Who We Are

Phillips Medisize, a Molex company, collaborates with industry leaders to design and manufacture drug delivery systems, medical devices and diagnostic tools that save and improve the quality of life for millions of patients annually. With our dedicated team of 6,000+ employees in 29 locations around the world, we share our customers’ mindset that every product is critical to a healthcare provider and their patients somewhere in the world. Molex is multi-sector global electronics brand owned by Koch, Inc., one of the world’s largest privately held companies. Discover your potential to make a difference.

At Koch, employees are empowered to do what they do best to make life better. Learn how our business philosophy helps employees unleash their potential while creating value for themselves and the company.

Additionally, everyone has individual work and personal needs. We seek to enable the best work environment that helps you and the business work together to produce superior results.