Staff Regulatory Affairs Specialist, Advertising & Promotion

We need to output HTML fragment with sections: About the role? The posting includes description. We need to use

for section headings: e.g., About the role, Responsibilities, Requirements, Qualifications, Skills, Benefits, Pay, Schedule. Only include sections when posting has real specific content. We have responsibilities list, requirements (minimum requirement), knowledge and skills, benefits (health and well-being, retirement, life balance programs), pay (salary range), schedule (hybrid position: required to be in office min 4 days a week, office location Franklin Lakes, NJ). Also maybe "About the role" could be the introductory paragraph. We must not repeat job title as heading. No Job ID etc. Remove boilerplate: EEO, etc. Also remove navigation, cookie, legal, scam warning, duplicated lines, application instructions. Also remove "We Are The People Who Give Possibilities Purpose BD is one of the largest global medical technology companies..." maybe that's part of about the role? It's introductory fluff but we can keep as prose under About the role. Must preserve all substantive information; do not invent or summarize away detail. So we need to include all details: responsibilities list, minimum requirement bullet? It's a paragraph; we can put as

• for each requirement? The instruction: Use
  • for any list of duties/requirements/benefits. So we should convert the responsibilities list into
    • . Also the minimum requirement could be a list? It's a paragraph with multiple bullet-like sentences? It says "Minimum Requirement B.S. degree ... Minimum 5 years Regulatory Affairs experience ... Experience reviewing labeling ... Experience supporting cross-functional ... Experience with medical device or IVD claims substantiation ...". We can treat each as a list item. Similarly Knowledge And Skills can be list. Benefits: many items; we can list them under Benefits. Pay: salary range. Schedule: hybrid position requirement. We must not include sections with placeholder text. All sections have content. We must output only HTML fragment, no /, no markdown fences. Let's structure:

      About the role

      ... introductory paragraph(s) ...

      Responsibilities

      • Lead regulatory review and approval of advertising, promotional, labeling, sales, educational, trade show, launch, and customer-facing materials for Specimen Management products.
      ...

      Requirements

      • B.S. degree in a scientific, health sciences, engineering, regulatory, or technical discipline (e.g., biology, chemistry, biomedical engineering, bioengineering, or related field).
      • Minimum 5 years Regulatory Affairs experience in medical device, IVD, diagnostics, life sciences, or similarly regulated healthcare products, or an equivalent combination of education and experience.
      • Experience reviewing labeling, advertising, promotional, commercial, or customer-facing materials for regulated products.
      • Experience supporting cross-functional product teams, marketing/commercial teams, launch activities, change assessments, and risk-based regulatory decisions.
      • Experience with medical device or IVD claims substantiation, performance evidence, labeling requirements, promotional review processes, and competitive claim governance preferred.

      Knowledge and Skills

      • Proficient in Microsoft Word, Excel, PowerPoint, and applicable electronic review/document management systems.
      • Strong written and verbal communication, technical writing, critical thinking, and project management skills.
      • Demonstrated ability to influence without authority, collaborate across functions, and manage multiple priorities concurrently.
      • Must have current knowledge of US, EU, and international medical device/IVD regulatory requirements related to labeling, claims, advertising, and promotion.
      • Must have strong understanding of claims substantiation, intended use alignment, evidence evaluation, and fair and balanced positioning.
      • Must have the ability to assess promotional risk and communicate practical, well-reasoned recommendations to Marketing, Legal, Quality, Medical Affairs, and Commercial stakeholders.
      • Must be self-motivated, detail-oriented, able to work independently, maintain confidentiality, and carry out responsibilities with minimal supervision.

      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
      • 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
      • 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
      • 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
      • 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
      • Bereavement leaves
      • Military leave
      • Personal leave
      • Family and Medical Leave (FML)
      • Jury and Witness Duty Leave

      Pay

      Salary Range: $135,500.00 - $216,800.00 USD Annual

      Schedule

      Hybrid position: required to be in the office a minimum of 4 days per week. Office location: Franklin Lakes, NJ.

      We must ensure no duplicate content. Also we should not include "At BD, we prioritize on-site collaboration..." maybe that's part of About the role or Schedule? It's about workplace arrangement; we could incorporate into About the role or Schedule. But we already have schedule section. The paragraph about on-site collaboration could be part of About the role. Let's include it in About the role paragraph. We need to preserve all substantive information: The initial fluff about BD purpose etc. Also the hybrid position statement about 4 days a week appears also in the "At BD, we prioritize on-site collaboration..." paragraph. We should not duplicate. We'll include that info in About the role or Schedule but not duplicate. Let's craft About the role paragraph: combine the introductory fluff and the description of BD – Specimen Management and the role focus. We need to avoid repeating job title. No mention of "Staff Regulatory Affairs Specialist" as heading but can be in prose. Let's write About the role:

      We Are The People Who Give Possibilities Purpose 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. In BD – Specimen Management (BD SM), we develop some of the most widely used products in the field of specimen collection including acquisition of the sample, collection into an appropriate container, and also emerging point-of-care applications. Our team has the unique opportunity to be involved with both medical devices and in vitro diagnostics, allowing you to broaden your expertise and grow in your career. Our Staff Regulatory Affairs Specialist position is primarily focused on compliant advertising and promotion of our existing Specimen Acquisition and Lab Specimen Management product portfolios, in addition to opportunities to provide regulatory support for new product claims. The ideal candidate will be energetic, possess a strong regulatory background and perform well independently and as part of a team. The Staff Regulatory Affairs Specialist will work in BD – Specimen Management providing regulatory leadership to cross-functional project teams from an advertising and promotional materials standpoint. The incumbent will be responsible for regulatory review and strategic guidance for promotional, advertising, labeling, educational, sales, and commercial materials for Specimen Management products. This role ensures claims and communications are truthful, non-misleading, appropriately substantiated, aligned to approved indications/intended use, and compliant with applicable US, EU, and global medical device/IVD requirements. The incumbent partners with Marketing, Medical Affairs, Legal, Quality, R&D, and Commercial teams to enable compliant advertising and promotional materials. The ideal candidate has strong medical device/IVD regulatory experience, sound judgment, excellent communication skills, and the ability to influence cross-functional teams with minimal supervision. Our people make all the difference in our success. Join us in our mission to advance the world of health. 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.

      But note: we should not include boilerplate like EEO etc. The paragraph about vaccination and accommodation may be considered boilerplate? It's about workplace policy; maybe it's not boilerplate but still part of posting. The instruction: Remove cookie/navigation/legal/EEO/equal-opportunity/scam-warning boilerplate. Vaccination and accommodation might be considered legal/EEO? Not sure. Safer to remove those sentences about vaccination and accommodation as they could be considered legal boilerplate. The instruction says remove EEO/equal-opportunity/scam-warning boilerplate. Vaccination requirement is not EEO but could be considered legal. However it's a specific condition; but it's likely part of standard boilerplate. I'd remove it to be safe. Also remove the sentence about "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." That seems like boilerplate. We'll cut it. Thus About the role paragraph ends before that. We also need to include the hybrid position statement about 4 days a week. That appears in the paragraph we kept: "At BD, we prioritize on-site collaboration