11+ FDA Jobs in Pune | FDA Job openings in Pune

Job Title : Medical Device Engineer

Location : Bangalore / Pune

Experience : 5+ Years total, with at least 3 years in Medical Device Development, Sustenance, or DHF Remediation

Notice Period : Immediate to 1 week

Interview Process : L1-selected candidates will undergo a customer interview

Mandatory Skills : Medical Device Development/Sustenance/DHF Remediation, ISO 13485, IEC 60601, ISO 14971, FDA & EU MDR compliance, DHF documentation, Design FMEA, CTS/CTQ, QMS, PLM, Verification & Validation, Impact Assessment.

Key Skills & Knowledge :

• Strong understanding of ISO 13485, IEC 60601, and ISO 14971 standards
• Experience with FDA and EU MDR regulatory requirements

Responsibilities :

• Conduct gap assessments and create/update DHF documents, including user and product requirements, design FMEA, CTS/CTQ, and standards compliance reports
• Analyze and implement design changes, assess impact, and update documentation accordingly
• Identify gaps in verification and validation, ensuring clear traceability between requirements and verification documents
• Assess compliance with applicable standards and regulations
• Define CTS/CTQ parameters and actively participate in design reviews
• Follow QMS guidelines and manage changes through PLM.

Wednesday Solutions is seeking a skilled and self-driven B2B Copywriter to join our dynamic team. This role is ideal for someone who thrives on converting ideas into impactful content that educates, engages, and drives results. You'll work closely with key personnel to capture the essence of what we do transform it into high-quality marketing assets.

Key Responsibilities:

• Content CreationWrite e-books that showcase expertise and thought leadership in our domain.
• Develop Email Education Courses (EEC) to nurture leads and provide actionable insights.
• Produce a weekly newsletter that informs, educates, and connects with our audience.
• Write social media posts that drive traffic and amplify engagement.
• Write compelling scripts for videos that captivate viewers and drive traffic.
• Workshops and CollaborationConduct workshops with key personnel to extract insights and data.
• Identify the tone of the brand voice to maintain consistency across all content.
• Translate discussions and ideas into polished content artifacts.
• Strategic ExecutionTake ownership of content projects from ideation to delivery, ensuring timely and high-quality outputs.
• Collaborate with cross-functional teams to align content with marketing objectives.
• Continuously refine content strategies to improve engagement and outcomes.

Outcomes Expected:

High-Quality Deliverables:

• Publish e-books.
• Launch Email Education Courses that educate and nurture the audience effectively.
• Distribute an engaging and informative weekly newsletter.
• Develop social media content that drives measurable traffic to key platforms.
• Craft impactful video scripts to boost engagement and brand awareness.

Effective Collaboration:

• Successfully conduct workshops to gather meaningful insights and align with stakeholders.
• Clearly define and adhere to the brand’s tone of voice in all outputs.

Autonomy and Accountability:

• Work independently, with minimal handholding, and deliver content that meets or exceeds expectations.
• Take ownership of deadlines and quality, demonstrating a strong sense of accountability.

Required Skills and Experience

• Proven Writing Expertise: Demonstrated ability to craft engaging and impactful B2B content across formats.
• Workshop Facilitation: Experience conducting interviews, workshops, or collaborative sessions with stakeholders.
• Self-Driven: Highly motivated, able to manage multiple projects with minimal supervision.
• Strategic Thinking: Ability to align content creation with broader marketing goals.
• Attention to Detail: A meticulous approach to maintaining consistency and quality across all deliverables.
• Digital Savvy: Understanding of content distribution strategies for email, social media, and digital platforms.

1. Market Research: Conduct thorough market research to identify potential clients, industry trends, and competitive landscape.
2. Prospecting and Lead Generation: Identify and reach out to potential clients through various channels, including cold calling, emails, and networking events.
3. Client Engagement: Build and maintain strong relationships with clients by understanding their needs and effectively communicating how our products/services can add value.
4. Sales Support: Collaborate with senior business development executives to develop proposals, presentations, and other sales materials. Assist in preparing and delivering client presentations.
5. Pipeline Management: Maintain a well-organized and updated sales pipeline, ensuring accurate tracking of leads, opportunities, and client interactions.
6. Achieving Targets: Work towards and achieve assigned sales targets and objectives within specified timelines.
7. Feedback and Improvement: Provide feedback from client interactions to internal teams, contributing to the continuous improvement of products/services.

Freshers can apply!

Job Title: Operations Intern

Location: Baner, Pune

What You'll Do:

Telecalling Mastery: Sharpen your communication skills as you engage with internal and external stakeholders, promoting our Software Product, and generating leads.

Lead Generation: Utilize your communication expertise to identify and connect with potential clients. You're the bridge to new opportunities.

Collaboration: Work closely with cross-functional teams to ensure smooth operations and execution of strategies.

What We're Looking For:

Excellent Communicator: Your ability to communicate effectively is your superpower.

Eager Learner: A hunger for knowledge and a passion for staying ahead in the IT game.

Team Player: Collaboration is the key to our success.

Initiative-Taker: Proactive problem-solver who seizes opportunities.