QA/RA Specialist

POSITION TITLE: Senior QA/RA Specialist
JOB LOCATION: Bangalore,India
DEPARTMENT: Quality & Regulatory
REQUIRED EDUCATION: Bachelor's degree in biomedical engineering discipline or equivalent

engineering degree
KEY RESPONSIBILITIES: ➢ Product QA/RA:

• Provide quality and regulatory affairs input to the product
development team and handle all QA & RA responsibilities
throughout product development, design change and post market
surveillance process

• As part of core team, work with engineering team to ensure
Project team follows Quality system and PRD process, appropriate execution, and documentation of design control activities (e.g.,
Design Inputs, Design Outputs, Design Verification)

• Plan and support project milestone reviews

• Provide the engineering and manufacturing team with the relevant
quality and regulatory affairs requirements as part of Product
Design Inputs for further product development and process
validation requirements

• Lead regulatory submissions in alignment with guidance from your
supervisor

• Support in discussions with regulatory auditors regarding medical
device quality and regulatory matters as necessary

• Demonstrate attention to detail, flexibility, and awareness of
production and quality control issues

• Responsible for ensuring that product labeling and packaging
comply with regulatory requirements, including accuracy of
information, proper use of symbols, and adherence to labeling
guidelines and approve the labelling requirement and plan as
assigned
➢ QMS (Quality Management System) Management:

• Be responsible for establishing approved documents, maintain and
continuously improve Quality System processes required by
international, regional and national regulatory authorities and
standards e.g., 93/42/EEC, Regulation (EU) 2017/745,
ISO13485:2016, FDA QSR))

• Establish and analyze key performance indicators to evaluate
and continuously improve the QMS

• Lead discussions with regulatory auditors regarding medical device
quality and regulatory matters as needed. Will be assigned as key
auditee during external audits as necessary

• Oversee CAPA meetings and management of effective CAPA
implementation

• Provide regulatory guidance and support to internal teams and
stakeholders. This includes communicating changes in regulations,
conducting training on quality and regulatory requirements, and
fostering a culture of compliance within the organization
➢ Risk:

• Collaborate with the Risk Management Team to support the
assessment and mitigation of risks associated with product quality
and regulatory compliance. This involves identifying potential risks
throughout the product lifecycle and implementing effective
strategies to minimize or eliminate them

• Ensures consistent RM reports are available for all products

• Provides oversight on risk assessments, including post-market
evaluations
➢ Post Market Surveillance:

• Develop, revise, manage and administer PMS plans, conduct
reviews and reports as required by department manager and in
accordance with approved procedures

• Provide support for PMS activities on relevant product data
requirement

SKILLS &
RESPONSIBILITIES:

• Minimum 5+ years QA or regulatory experience in medical industry

• Bachelor's degree in biomedical engineering discipline or
equivalent engineering degree

• Working knowledge of appropriate global medical device
regulations, requirements, and standards, such as ISO 13485, 21
CFR Parts 803, 806, and 820, ISO14971, European Medical Device
Directive (93/42/EEC), EU MDR (2017/745)

• Has wide-range experience, uses professional concepts and
company objectives to resolve complex issues in creative and
effective ways

• Experience interacting with the FDA, and Other Regulatory
Authorities

• Good time-management skills

• Strong English verbal and written communication skills
Demonstrate strong critical thinking skills to evaluate and
investigate customer complaints, determining the need for CAPA
and MDR

• Show willingness and ability to learn new processes and suggest
options for compliance and efficiency

• Excellent Analytical skills and ability to synthesize trending data
into meaningful information for the organization

• Demonstrate leadership; attention to detail and ability to solve
problems and communicate issues;

• Ability to work on multiple projects and to learn and implement
company policies, procedures, and work instructions