Regulatory Affairs Associate

Job Title: Regulatory Affairs Associate – Medical DevicesJob Description

The Regulatory Affairs Associate supports medical device projects by developing and implementing regulatory strategies, ensuring compliance with international standards, and integrating regulatory requirements throughout the product lifecycle. This role partners closely with cross-functional teams to maintain accurate regulatory documentation and uphold robust design control practices for innovative medical technologies, including software as a medical device and combination products.

Responsibilities

• Develop and execute regulatory strategies for medical device projects, including software as a medical device (SaMD) and combination products.
• Ensure compliance with international regulations and standards, including FDA requirements, ISO standards, IEC standards, and other applicable regulatory frameworks.
• Collaborate with R&D, Quality, Clinical, and Manufacturing teams to integrate regulatory requirements into product design, development, and lifecycle management.
• Maintain comprehensive and accurate regulatory documentation to support submissions, approvals, and ongoing compliance activities.
• Support design control activities by ensuring regulatory considerations are documented and implemented throughout the development process.
• Contribute to regulatory planning for new product development and lifecycle management, including changes, updates, and post-market activities.
• Monitor relevant regulatory guidance and standards to help keep internal processes and documentation aligned with current expectations.
  
  

Essential Skills

• Demonstrated experience in regulatory affairs for medical devices.
• Hands-on experience working with software as a medical device (SaMD) or combination products.
• Strong understanding of FDA regulatory requirements for medical devices.
• Ability to prepare, review, and maintain regulatory documents and technical files.
• Experience supporting design control activities and integrating regulatory requirements into product development.
• Proficiency in collaborating with cross-functional teams such as R&D, Quality, Clinical, and Manufacturing.
• Attention to detail and strong organizational skills for managing regulatory documentation and compliance activities.
  
  

Additional Skills & Qualifications

• Knowledge of international regulatory pathways, such as Health Canada, TGA, and PMDA.
• Familiarity with ISO and IEC standards relevant to medical devices and software.
• Certification in Regulatory Affairs (RAC) is a plus.
• Prior involvement in new product development and lifecycle management for medical devices.
• Ability to interpret and apply evolving international regulatory guidance to internal processes.
• Strong written and verbal communication skills for regulatory correspondence and cross-functional collaboration.
  
  

Work Environment

The role operates in a collaborative, cross-functional environment that brings together R&D, Quality, Clinical, and Manufacturing teams to deliver safe and effective medical devices. Work is primarily office-based, with extensive use of standard business software tools for documentation, regulatory submissions, and communication. The position involves working with technical and quality management systems aligned to FDA, ISO, and IEC standards, and requires careful documentation practices and adherence to established procedures. Professional attire suitable for a corporate or technical office setting is expected.

Diversity, Equity & Inclusion

At Actalent, Diversity And Inclusion Are a Bridge Towards The Equity And Success Of Our People. DE&I Is Embedded Into Our Culture Through

• Hiring diverse talent
• Maintaining an inclusive environment through persistent self-reflection
• Building a culture of care, engagement, and recognition with clear outcomes
• Ensuring growth opportunities for our people
  
  

Actalent is an equal opportunity employer.

About Actalent

Actalent is a global leader in engineering and sciences services. For more than 40 years, we've helped visionary companies advance their goals. Headquartered in the United States, our teams span 150 offices across North America, EMEA, and APAC—with four delivery centers in India led by 1,000+ extraordinary employees who connect their passion with purpose every day.

Our Bangalore, Hyderabad, Pune, and Chennai delivery centers are hubs of engineering expertise, with core capabilities in mechanical and electrical engineering, systems and software, and manufacturing engineering. Our teams deliver work across multiple industries including transportation, consumer and industrial products, and life sciences. We serve more than 4,500 clients, including many Fortune 500 brands. Learn more about how we can work together at actalentservices.com.