Maven Profcon Services LLP is hiring for multiple positions in Ahmedabad across medical device regulatory consulting, quality assurance, digital marketing, administration, and AI/ML.

Job Details

Positions

1. Senior Executive – QARA

Eligibility & Experience:

• Bachelor’s/Master’s degree in Biomedical Engineering, Biotechnology, Life Sciences, Pharmacy, Regulatory Affairs, Quality Management, or a relevant field.
• 3+ years of relevant experience in QA/QMS, medical device regulatory affairs, AMC, or regulatory consulting.
• Experience in medical device consultancy is mandatory.

Required Skills:

• ISO 13485
• QMS and Internal Audits
• CAPA/NC management and MRM
• Technical documentation and review
• Analytical skills
• Client communication and team management
• Ability to independently manage multiple projects and deliverables

2. Senior Regulatory Executive – EU MDR 2017/745

Eligibility & Experience:

• Bachelor’s or Master’s degree in Life Sciences, Biomedical Engineering, Pharmacy, or a related field.
• 2–4 years of hands-on regulatory affairs experience in the medical device industry.

Required Skills:

• EU MDR 2017/745
• Clinical, risk, and performance documentation
• ISO 14971
• MEDDEV guidance
• FDA 21 CFR Part 820
• 510(k) submission process
• Communication, documentation, and project management
• Ability to manage multiple projects and deadlines

3. Executive Assistant

Eligibility & Experience:

• Bachelor’s or Master’s degree in any discipline.
• 0–1 years of experience in administrative or executive assistant roles is preferred.

Required Skills:

• Verbal and written communication
• Organisation and multitasking
• MS Office: Word, Excel, PowerPoint, and Outlook
• Task prioritisation
• Professionalism
• Attention to detail
• Proactive approach and quick learning

4. Senior Digital Marketing Executive

Eligibility & Experience:

• Bachelor’s/Master’s degree in Computer Application, Marketing, or a related field.
• 3–4 years of experience in digital marketing, preferably with hands-on SEO and website management experience.

Required Skills:

• SEO and keyword research
• Google Analytics 4
• Google Search Console
• Google Ads and Meta Ads
• Lead generation
• Content writing
• Social media management
• Reporting and analytics
• HTML, CMS, website backend, plugins, and technical SEO
• Communication, coordination, and project management

5. Junior AI-ML Engineer

Experience:

• 6 months to 1 year of experience.

Required Skills:

• ML integration with JavaScript/Node.js applications
• TensorFlow.js or model conversion for JavaScript
• Document classification using ML
• RESTful API design and architecture
• Machine learning expertise in NLP and document generation
• Production ML model development and deployment
• Python
• TensorFlow, PyTorch, and other ML frameworks
• API design and integration patterns
• Text processing and generation techniques

6 Junior Regulatory Executive – EU MDR 2017/745

Location: Makarba, Ahmedabad, Gujarat

Employment Type: Full Time

Key Responsibilities:

• Develop, review, and maintain regulatory documentation in accordance with EU MDR 2017/745, including technical documentation, risk management files, and clinical evaluation reports.
• Conduct gap assessments against EU MDR requirements to identify areas for improvement and support implementation strategies.
• Coordinate with cross-functional teams to gather data and ensure alignment of regulatory submissions with product design and development processes.
• Stay updated on relevant regulatory testing requirements and ensure compliance with applicable standards.
• Support the preparation of Notified Body submissions, responses to queries, and audit readiness.
• Interpret global regulatory requirements and translate them into clear guidance and actionable plans for internal and client teams.

Qualifications & Skills:

Ability to work independently, prioritise tasks, and manage deadlines across multiple projects.

Bachelor’s or Master’s degree in life sciences, biomedical engineering, pharmacy, or a related field.

Minimum 6 months of hands-on experience in regulatory affairs within the medical device industry.

Demonstrated expertise in EU MDR 2017/745, with experience preparing clinical, risk, and performance documentation.

Strong understanding of ISO 14971 and MEDDEV guidance.

Excellent communication, documentation, and project management skills.

Application Details

Interested candidates can apply for the listed positions through the provided application link or share their application at:

Email: careers@mavenprofserv.com

Application Link