Senior Regulatory Affairs

Saraca Solutions; Bengaluru; On-site; INR 1,500,000 - 2,500,000; Full time

Job summary

Saraca Solutions is seeking a Senior Regulatory Affairs professional to lead regulatory submissions for medical devices and combination products in the US and EU. You will coordinate with FDA, Notified Bodies, and authorities, ensuring compliance and timely approvals for product launches.

Responsibilities include drafting submissions, handling post-market reports, and supporting cross-functional teams during development and change control processes.

Qualifications

• Minimum 1-year experience in FDA regulated industry.
• Working knowledge of Medical Device Regulations (FDA and EU).
• Direct interaction with FDA reviewers/inspectors.
• Team based work environment experience preferred.
• Strong communication and planning skills.

Responsibilities

• Participate on product development teams to ensure US/EU regulatory requirements are incorporated.
• Author submissions and regulatory documents for market approvals of devices/combination products.
• Assist in post-market submissions and annual reports.
• Support marketing, R&D and manufacturing in regulatory assessments of changes.
• Interface with FDA, Notified Bodies and authorities under supervision.

Skills

EU MDR

US FDA

MDD to MDR Transition

Change Control

Education

Bachelor’s Degree or equivalent

RAC certification preferred

Job description

Desired Skills: EU MDR, US FDA, MDD TO MDR Transition, Change Control

Job Description

Job description

Division: Spine Job title: Senior Regulatory Affairs

Specialist

Function: Regulatory Affairs

Travel: 10%

Location:

(City, State or Country) Bangalore/Gurgaon

People

manager: No

Position summary:

• Planning, organizing and implementing strategies and activities required to procure regulatory
  approval for new and revised product lines under the guidance of more senior regulatory
  professionals.
• Ensuring compliance to all US, EU and Spine requirements and corporate policies and
  procedures regarding submissions and other requirements for market approval of medical
  devices/combination products.
• Participating in cross functional team activities from initial stages through securing government
  approvals.
• Applying scientific principles to understanding safety and efficacy on a wide range of products

Essential duties & responsibilities: (detailed description)

• Participate on product development teams to insure US and EU regulatory requirements are
  incorporated as part of the development process
• Author submissions and other regulatory documents to obtain approval to bring new or modified
  products to market
• Assist in post market submissions (progress reports, annual reports etc.)
• Support marketing, R&D and manufacturing teams in regulatory assessment of proposed
  changes or product transfers
• Address and advise teams on appropriate pathways to market under the supervision of more
  experienced regulatory professionals
• Interface and coordinate with the FDA, Notified Bodies, Competent Authorities and other
  regulatory agencies on submissions, approvals or other issues under the supervision of more
  experienced regulatory professionals
• Establish and maintain regulatory information systems both electronically and hard copy
• Interpret existing and/or new regulatory requirements as they relate to company products and
  procedures. Communicate this to appropriate personnel
• Review and approve product and manufacturing changes while considering both US and EU
  regulatory requirements
• Prepare and update US product listings and EU registrations
• Communicate any FDA correspondence on submissions to the appropriate team(s) and RA
  management
• Conduct labeling, marketing, product transfer and literature review pre and post market under
  the supervision of a more experienced regulatory professional
• Prepare Technical files and Design Dossiers to support CE Marking under the supervision of a
  more experienced regulatory professional
• Assist the RA Managers and others with the development, implementation and maintenance of
  regulatory SOP's
• Participate in other regulatory projects as assigned

Education & special trainings:

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• Bachelor’s Degree or equivalent combination of education and experience, required; RAC
  certification preferred

Qualifications & experience:

• 510(k) and CE Marking; IDE, PMA (original/revision/supplements) preparation a plus
• Minimum 1-year experience in FDA regulated industry
• Working knowledge of Medical Device Regulations (FDA and EU required)
• Direct interaction with FDA reviewers/inspectors
• Team based work environment experience preferred
• Strong interpersonal, written, oral, communication, organizational and planning skills
• Working knowledge of personal computer systems and desktop office applications
• Sound understanding of scientific principles

Physical & mental requirements:

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.
Requirements listed here are representative of knowledge, skill, and/or ability required. Reasonable
accommodations may be made to enable individuals with disabilities to perform essential functions.

SARACA is a rapidly growing product engineering services company with deep expertise in digital, artificial intelligence, and emerging new technologies. Founded in 2014, SARACA is powered by Gen Z and Millennials with greater focus on agility, customer centricity, faster technology adoption, and adherence to cultural sensitivity. Our digital natives perform their actions with speed and ensure that we exceed customer expectation every single time. SARACA adopted vertically integrated approach to build depth in the industries we operate in. Over the years we have built strong expertise in aerospace, defense, space, automotive, medical devices, Industrial, Farm Equipment, rail transportation, technology, semiconductor, and many other industries.

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