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 setting.

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.

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.

📌 Regulatory Affairs specialist (India)
🏢 Phillips-Medisize
📍 India