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$11

$48

$85

How much do combination products jobs pay per hour?

As of Jul 7, 2026, the average hourly pay for combination products in the United States is $48.01, according to ZipRecruiter salary data. Most workers in this role earn between $26.68 and $65.38 per hour, depending on experience, location, and employer.

What are the key skills and qualifications needed to thrive as a Combination Products Specialist, and why are they important?

To thrive as a Combination Products Specialist, you need a solid background in biomedical engineering, pharmaceuticals, or related sciences, often with experience in regulatory affairs or quality assurance. Familiarity with FDA regulations (21 CFR Part 4), ISO 13485, and risk management tools like FMEA is typically required. Strong attention to detail, analytical thinking, and effective cross-functional communication are crucial soft skills in this role. These competencies ensure compliance, product safety, and successful collaboration throughout the product lifecycle.

What is the difference between Combination Products vs Pharmaceutical Manufacturing Specialists?

AspectCombination ProductsPharmaceutical Manufacturing Specialists
Required CredentialsRegulatory knowledge, engineering, quality assurancePharmacy, chemistry, manufacturing certifications
Work EnvironmentMedical device and drug integration settingsPharmaceutical production facilities
Employer & Industry UsageMedical device and pharmaceutical industriesPharmaceutical companies and contract manufacturers
Common Search & Comparison IntentUnderstanding roles in drug-device combination developmentManufacturing processes and quality control in pharma

Combination Products professionals focus on integrating drugs and medical devices, requiring knowledge of both regulatory and engineering aspects. Pharmaceutical Manufacturing Specialists concentrate on drug production processes, emphasizing chemistry and manufacturing expertise. While both roles operate within the pharmaceutical industry, their focus areas differ, making this comparison relevant for those exploring careers or partnerships in drug-device development and manufacturing.

What are some common challenges faced by professionals working in Combination Products roles, and how can they be addressed?

Professionals in Combination Products roles often encounter challenges related to navigating complex regulatory requirements, as these products involve both medical devices and pharmaceuticals or biologics. Coordinating cross-functional teams—including R&D, regulatory, quality, and manufacturing—can also be demanding due to differing processes and timelines. To address these challenges, it's important to develop strong project management skills, maintain clear communication among stakeholders, and stay up-to-date with evolving regulations from agencies like the FDA and EMA. Building expertise in both device and drug development processes will also help you collaborate more effectively and ensure successful product development.

What are combination products?

Combination products are therapeutic and diagnostic products that combine two or more types of medical products, such as a drug and a device, a device and a biological product, or a drug and a biological product. These products are designed to work together to provide a unique medical benefit that cannot be achieved by any single component alone. Examples include pre-filled syringes, drug-eluting stents, and inhalers with medication. Combination products are regulated by the FDA and require specialized approval pathways to ensure their safety and effectiveness.
More about Combination Products jobs
What states have the most Combination Products jobs? States with the most job openings for Combination Products jobs include:
What job categories do people searching Combination Products jobs look for? The top searched job categories for Combination Products jobs are:
Combination Products jobs near you
Infographic showing various Combination Products job openings in the United States as of July 2026, with employment types broken down into 89% Full Time, 10% Part Time, and 1% Contract. Highlights an 94% Physical, 2% Hybrid, and 4% Remote job distribution, with an average salary of $99,860 per year, or $48 per hour.
Head of Quality, Device and Combination Products

Head of Quality, Device and Combination Products

Biogen

Cambridge, MA • Hybrid

Full-time

Medical, Dental, Vision, Life, Retirement, PTO

Posted 27 days ago

Biogen rating

9.3

Company rating: 9.3 out of 10

Based on 19 frontline employees who took The Breakroom Quiz

2nd of 73 rated pharmaceutical

Job description

About This Role:
As the Head of Quality for Device and Combination Products, you will lead the development and execution of the global quality strategy, focusing on devices and combination products. This role involves establishing cross-functional roles and serving as the primary quality representative for drug-device combination engagements. You will oversee the Global Quality Device organization, ensuring quality management across all stages from design to lifecycle activities. Your role is critical in ensuring inspection readiness and aligning regulatory regulations within Biogen's quality system, integrating engineering design and risk management. Your leadership will drive compliance with regulatory and quality standards while fostering continuous improvement, ultimately supporting the uninterrupted supply and compliant lifecycle management of devices and combination products.

This is a hybrid-based role to be located at our Headquarters in Cambridge, MA.

What You'll Do:

  • Develop and implement quality business strategies for internal and external device/combination product programs.

  • Lead the global quality team supporting design, development, manufacturing, and quality operations.

  • Lead and support transfers, deviations, investigations, and CAPAs.

  • Ensure execution of a robust, compliant QMS for end-to-end lifecycle management.

  • Participate in Health Authority audits and management reviews.

  • Ensure oversight of GxP activities and provide quality engineering guidance.

  • Lead or support continuous improvement of the Device and Combination Product QMS.

  • Represent Quality Operations on cross-functional initiatives and development programs.

  • Support internal, external, CMO audits, certifications, and regulatory inspections.

Who You Are:


You are a visionary leader with a deep understanding of quality management systems and regulatory standards. Your ability to build strong relationships with internal and external counterparts is exceptional, and you thrive in collaborative environments. You possess a strategic mindset and are adept at navigating complex challenges with innovation and expertise. Your passion for continuous improvement and dedication to compliance drives you to maintain the highest standards of quality. In this role, your resilience and adaptability will be key as you lead teams in a fast-paced, dynamic setting.

Required Skills:

  • BS in Chemical Engineering, Mechanical Engineering, or relevant field

  • A minimum of 12 years of medical device quality, engineering, and packaging experience with at least 5 years in clinical quality operations and/or device quality.

  • Comprehensive knowledge of 21 CFR 820, 21 CFR Part 4, ISO 13485, ISO 14971, and EU Medical Device Regulation.

  • Experience in engaging with regulatory authorities and notified bodies.

  • Experience in people management (>5 years) and project management.

  • Strong understanding of CMO-mediated Supply Chain activities.

  • Experience working in international matrix environments.

  • Expert knowledge of supplier management and relations, including negotiation skills.

  • Experience with process development and validation.


Job Level: Management


Additional Information

The base compensation range for this role is: -


Base salary offered is determined through an analytical approach utilizing a combination of factors including, but not limited to, relevant skills & experience, job location, and internal equity.

Regular employees are eligible to receive both short term and long-term incentives, including cash bonus and equity incentive opportunities, designed to reward recent achievements and recognize your future potential based on individual, business unit and company performance.

In addition to compensation, Biogen offers a full and highly competitive range of benefits designed to support our employees' and their families physical, financial, emotional, and social well-being; including, but not limited to:

  • Medical, Dental, Vision, & Life insurances
  • Fitness & Wellness programs including a fitness reimbursement
  • Short- and Long-Term Disability insurance
  • A minimum of 15 days of paid vacation and an additional end-of-year shutdown time off (Dec 26-Dec 31)
  • Up to 12 company paid holidays + 3 paid days off for Personal Significance
  • 80 hours of sick time per calendar year
  • Paid Maternity and Parental Leave benefit
  • 401(k) program participation with company matched contributions
  • Employee stock purchase plan
  • Tuition reimbursement of up to $10,000 per calendar year
  • Employee Resource Groups participation

Why Biogen?

We are a global team with a commitment to excellence, and a pioneering spirit. As a mid-sized biotechnology company, we provide the stability and resources of a well-established business while fostering an environment where individual contributions make a significant impact. Our team encompasses some of the most talented and passionate achievers who have unparalleled opportunities for learning, growth, and expanding their skills. Above all, we work together to deliver life-changing medicines, with every role playing a vital part in our mission. Caring Deeply. Achieving Excellence. Changing Lives.

At Biogen, we are committed to building on our culture of inclusion and belonging that reflects the communities where we operate and the patients we serve. We know that diverse backgrounds, cultures, and perspectives make us a stronger and more innovative company, and we are focused on building teams where every employee feels empowered and inspired.Read onto learn more about our DE&I efforts.

All qualified applicants will receive consideration for employment without regard to sex, gender identity or expression, sexual orientation, marital status, race, color, national origin, ancestry, ethnicity, religion, age, veteran status, disability, genetic information or any other basis protected by federal, state or local law. Biogen is an E-Verify Employer in the United States.

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About Biogen

Sourced by ZipRecruiter

At Biogen, our mission is clear - we are pioneers in neuroscience. Biogen discovers, develops, and delivers worldwide innovative therapies for people living with serious neurological and neurodegenerative diseases. Together, our employees create, commercialize, and manufacture transformative therapies for our patient population.

Industry

Scientific research and development services

Company size

5,001 - 10,000 Employees

Headquarters location

Cambridge, MA, US

Year founded

1978

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