Associate Director, Labeling & Technical Writer

Associate Director, Senior Technical Writer

BD is one of the largest global medical technology companies in the world. Advancing the world of health™ is our Purpose, and it's no small feat. It takes the imagination and passion of all of us—from design and engineering to the manufacturing and marketing of our billions of MedTech products per year—to look at the impossible and find transformative solutions that turn dreams into possibilities.

Job Summary:

The Associate Director, Senior Technical Writer is a strategic documentation leader responsible for driving the development, quality, and evolution of technical documentation for Class II medical devices. This role combines deep expertise in technical writing with strong people leadership, cross-functional influence, and operational excellence. The ideal candidate brings extensive regulatory experience, excellent communication skills, and the ability to lead a high-performing team while collaborating across diverse business functions.

Key Responsibilities:

• Leadership & Team Management
• Lead, develop, and mentor a team of technical writers, illustrators, and/or documentation specialists; provide coaching, performance feedback, and career development.
• Build a high-performing documentation function by establishing clear expectations, aligning team goals to organizational priorities, and fostering a culture of quality, accountability, and continuous improvement.
• Oversee resource planning, workload balancing, and vendor/contractor management as needed.
• Represent the documentation function in leadership forums and influence decisions affecting product development, quality, labeling, and regulatory deliverables.
• Documentation Strategy & Oversight
• Own the end-to-end documentation lifecycle for customer-facing and internal technical content including user manuals, IFUs, installation guides, troubleshooting guides, upgrade/downgrade instructions, and documentation for global regulatory submissions.
• Ensure compliance with FDA, EU MDR, ISO 13485, and other relevant standards; embed regulatory and quality requirements into documentation workflows.
• Establish, maintain, and enforce documentation standards, best practices, templates, and style guides across all product lines.
• Drive documentation quality through consistent editorial review, standardization, and improvement of content clarity, structure, and usability.
• Cross-Functional Influence & Collaboration
• Partner with engineering, quality assurance, regulatory affairs, clinical/medical affairs, marketing, customer support, and global business units to gather information, validate content, and align documentation with product requirements.
• Lead the creation and review of IFU design specifications and quality documentation, collaborating with subject matter experts to ensure clinical and regulatory accuracy.
• Serve as the documentation authority in cross-functional meetings, influencing project scope, timelines, and risk mitigation strategies.
• Communicate effectively with senior-level stakeholders and international partners, ensuring alignment and timely delivery of all documentation commitments.
• Content Creation & Technical Expertise
• Create and edit technical documents with a high degree of accuracy, clarity, and regulatory compliance.
• Develop visual content including diagrams, illustrations, flow charts, line art, and product photography; advise engineering teams on data visualization and content usability.
• Stay current on industry trends, regulatory developments, and advancements in technical communication tools and methodologies.
• Program & Project Management
• Manage documentation schedules, dependencies, resource requirements, and deliverables within fast-paced project environments.
• Drive process improvements to increase efficiency, reduce cycle times, and enhance documentation quality.
• Oversee version control, change management, and documentation integration within enterprise systems.

Required Qualifications:

• Bachelor's degree in Technical Communication, Engineering, or a related technical or communications field required.
• 7+ years of experience in technical writing, technical communication, or documentation development required.
• 5+ years of experience within a regulated industry (medical devices strongly preferred; pharma/biotech acceptable).
• 3+ years of people leadership experience, including managing writers, contractors, or cross-functional documentation teams required.

Preferred Qualifications:

• Master's degree in Technical Communication, Regulatory Science, Engineering, Biomedical Engineering, Life Sciences, or a related discipline
• Prior leadership of technical writing teams within a medical device organization.
• Extensive experience in regulated industries such as medical devices or pharmaceuticals, with deep knowledge of regulatory compliance and documentation requirements.
• Demonstrated leadership experience managing teams or cross-functional documentation programs.
• Strong collaboration skills working with engineering, marketing, clinical, quality, and regulatory teams.
• Proven ability to manage multiple complex projects under tight deadlines.
• Strong initiative, problem-solving skills, and ability to work independently with minimal supervision.
• Familiarity with electro-mechanical systems and software applications.
• Experience with device labeling and packaging content.
• Knowledge of engineering change control processes and Agile methodologies.
• Experience with ERP systems such as SAP or Oracle.
• Proficiency with version control systems (Perforce, Subversion, TFS, GitHub).
• Skilled in technical editing tools (Microsoft Word, Acrobat, editorial symbols).
• Proficiency with DTP tools (MadCap Flare, Adobe FrameMaker, InDesign, Illustrator, XML, DITA).
• Experience with photography and image editing (Adobe Photoshop).
• Experience working with global regulatory submissions and country-specific documentation requirements.

At BD, we prioritize on-site collaboration because we believe it fosters creativity, innovation, and effective problem-solving, which are essential in the fast-paced healthcare industry. For most roles, we require a minimum of 4 days of in-office presence per week to maintain our culture of excellence and ensure smooth operations, while also recognizing the importance of flexibility and work-life balance. Remote or field-based positions will have different workplace arrangements which will be indicated in the job posting.

For certain roles at BD, employment is contingent upon the Company's receipt of sufficient proof that you are fully vaccinated against COVID-19. In some locations, testing for COVID-19 may be available and/or required. Consistent with BD's Workplace Accommodations Policy, requests for accommodation will be considered pursuant to applicable law.

At BD, we are committed to supporting our associates' well-being, development, and success through a performance-based culture. For this position, BD offers a competitive compensation package along with the following benefits specific to this role:

• Annual Bonus
• Health and Well-being Benefits: Medical coverage, Health Savings Accounts, Flexible Spending Accounts, Dental coverage, Vision coverage, Hospital Care Insurance, Critical Illness Insurance, Accidental Injury Insurance, Life and AD&D insurance, Short-term disability coverage, Long-term disability insurance, Long-term care with life insurance.
• Other Well-being Resources: Anxiety management program, wellness incentives, sleep improvement program, diabetes management program, virtual physical therapy, emotional/mental health support programs, weight management programs, gastrointestinal health program, substance use management program, musculoskeletal surgery, cancer treatment, and bariatric surgery benefit.
• Retirement and Financial Well-being: BD 401(k) Plan, BD Deferred Compensation and Restoration Plan, 529 College Savings Plan, financial counseling, Baxter Credit Union (BCU), Daily Pay, college financial aid and application guidance.
• Life Balance Programs: Paid time off (PTO), including all required State leaves, educational assistance/tuition reimbursement, MetLife Legal Plan, group auto and home insurance, pet insurance, commuter benefits, discounts on products and services, Academic Achievement Scholarship, Service Recognition Awards, employer matching donation, workplace accommodations.
• Other Life Balance Programs: Adoption assistance, backup day care and eldercare, support for neurodivergent adults, children, and caregivers, caregiving assistance for elderly and special needs individuals, Employee Assistance Program (EAP), paid parental leave, support for fertility, birthing, postpartum, and age-related hormonal changes.
• Leave Programs: Bereavement leaves, Military leave, Personal leave, Family and Medical Leave (FML), Jury and Witness Duty Leave.

Primary Work Location: USA CA - San Diego Bldg A&B

Additional Locations: USA CA - Irvine Laguna Canyon, USA NJ - Franklin Lakes

Work Shift: