Sr Associate- Regulatory

Job Title: Sr. Associate

Job Description

We are seeking a Sr. Associate with 3-5 years of experience in regulatory engineering or regulatory affairs within the medical device industry. The ideal candidate will have the expertise to develop and execute regulatory strategies, ensuring compliance with international regulations.

Responsibilities

• Develop and execute regulatory strategies for medical device projects.
• Prepare and submit regulatory filings such as FDA 510(k), PMA, and EU MDR submissions.
• Ensure compliance with international regulations including FDA, EU MDR, and ISO standards.
• Collaborate with R&D, Quality, Clinical, and Manufacturing teams to integrate regulatory requirements into product development.
• Maintain regulatory documentation and support design control activities.
• Monitor changes in global regulatory requirements and assess their impact on products.
• Support internal and external audits, inspections, and regulatory authority interactions.
• Provide guidance on labeling, advertising, and promotional materials to ensure compliance.
• Assist in risk management and post-market surveillance activities.
  
  

Essential Skills

• Bachelor’s degree in engineering, Regulatory Affairs, Life Sciences, or related field.
• 3–5 years of experience in regulatory engineering or regulatory affairs within medical devices.
• Strong knowledge of FDA regulations (21 CFR Part 11, 21 CFR Part 820), EU MDR, and international standards.
• Experience with regulatory submissions such as 510(k) and Technical Files.
• Familiarity with risk management standards (ISO) and design control requirements.
• Excellent communication, documentation, and organizational skills.
• Ability to work effectively in cross-functional teams and manage multiple projects.
  
  

Additional Skills & Qualifications

• Experience with software as a medical device (SaMD) or combination products.
• Knowledge of international regulatory pathways such as Health Canada, TGA, PMDA.
• Certification in Regulatory Affairs (RAC) is a plus.
• Prior involvement in new product development and lifecycle management.
  
  

Work Environment

The role requires collaboration with various teams including R&D, Quality, Clinical, and Manufacturing. The work environment is dynamic and fast-paced, focusing on the development of cutting-edge medical devices. The candidate will use a variety of technologies and tools to ensure compliance and successful regulatory submissions.

Work Experience

3-5 years

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.

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