Specialist - Regulatory Affairs - Medical Devices

Description:

Role: Regulatory Affairs Specialist Software as a Medical Device (SaMD)

Experience: 6 - 10 Years

Location: Pune / Bangalore

Notice Period: Immediate to 30 Days

Role Overview:

- Lead and support regulatory activities for Software as a Medical Device products

- Ensure compliance with US FDA and global regulatory requirements

- Act as a subject matter expert for SaMD regulatory submissions and audits

Key Responsibilities:

- Manage end-to-end regulatory submissions for SaMD products

- Prepare, review, and submit FDA filings including 510(k), Q-Submissions, and Special 510(k)

- Ensure compliance with FDA Quality System Regulations including 21 CFR 11 and 21 CFR 820

- Support regulatory strategies for US FDA Class I and II medical devices

- Participate in regulatory interactions with US and OUS authorities

- Support regulatory inspections, audits, and deficiency response activities

- Collaborate with quality, engineering, and clinical teams to ensure regulatory alignment

- Interpret and apply regulatory requirements across product lifecycle

- Maintain regulatory documentation and submission readiness

- Monitor regulatory changes including EU AI Act and global SaMD regulations

Key Result Areas (KRAs):

- Timely and successful regulatory submissions and approvals

- Zero or minimal regulatory observations during audits and inspections

- Compliance with FDA and international regulatory requirements

- Effective management of regulatory risks and deficiencies

- Accuracy and completeness of regulatory documentation

- Strong cross-functional regulatory support for product development

Required Experience & Qualifications:

- 610 years of regulatory affairs experience in a regulated medical device environment

- Hands-on experience with Software as a Medical Device regulatory processes

- Bachelors degree in Engineering, Life Sciences, or related field

- Experience working with FDA-regulated products

Skill Sets:

- Strong expertise in FDA submissions and SaMD regulations

- In-depth knowledge of 510(k), Q-Submissions, and regulatory strategies

- Working knowledge of FDA QSR, 21 CFR 11, and 21 CFR 820

- Understanding of EU AI Act and global regulatory frameworks

- Experience with US FDA Class I and II medical devices

- ISO 13485 Auditor certification preferred

- Strong regulatory writing and documentation skills

- Excellent communication and stakeholder management abilities

- Ability to work independently in regulated and fast-paced environments