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Senior Director Medical Device Jobs (NOW HIRING)

Agomab

Senior Director, Medical Writing

Cambridge, MA · On-site

Senior Director, Medical Writing Department: Regulatory Affairs Employment Type: Permanent - Full Time Location: Agomab US Reporting To: Senior VP/Head of Regulatory Affairs Description This is a ...

BNY

Senior Director, Medical Director

Manhattan, NY

We're seeking a future team member for the role of Corporate Medical Director to join our People ... senior executives and cross-functional stakeholders on workforce health, medical benefit strategy ...

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Senior Director Medical Device information

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$39.5K

$142.9K

$279.5K

How much do senior director medical device jobs pay per year?

As of Aug 17, 2026, the average yearly pay for senior director medical device in the United States is $142,920.00, according to ZipRecruiter salary data. Most workers in this role earn between $101,500.00 and $161,000.00 per year, depending on experience, location, and employer.

What does a senior director in medical device do?

A Senior Director in Medical Device leads and manages teams responsible for the development, regulatory approval, and commercialization of medical devices. They oversee product strategy, ensure compliance with industry regulations, and collaborate with cross-functional teams such as R&D, marketing, and quality assurance. Their role also involves setting department goals, managing budgets, and building relationships with key stakeholders to drive business growth.

How does a senior director in medical device typically collaborate with cross-functional teams to drive product development?

As a Senior Director in Medical Device, you will regularly collaborate with diverse teams such as R&D, regulatory affairs, quality assurance, marketing, and manufacturing. Your role involves facilitating communication between departments to ensure product development aligns with both regulatory standards and market needs. You’ll often lead cross-functional meetings, set project priorities, and resolve bottlenecks to keep projects on track. This collaborative environment is crucial for successfully bringing innovative medical devices to market while meeting strict compliance and quality requirements.

What are the key skills and qualifications needed to thrive as a senior director in medical device, and why are they important?

To thrive as a Senior Director in Medical Devices, you need extensive experience in product development, regulatory compliance, and a strong background in life sciences or engineering, often supported by an advanced degree. Familiarity with FDA regulations, ISO standards, quality management systems, and project management tools is typically required. Leadership, strategic thinking, and excellent communication are essential soft skills for guiding cross-functional teams and driving innovation. These skills ensure the safe, compliant, and successful delivery of medical devices in a highly regulated and competitive industry.
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Senior Director Medical Device jobs near you
Infographic showing various Senior Director Medical Device job openings in the United States as of August 2026, with employment types broken down into 1% As Needed, 77% Full Time, 15% Part Time, and 7% Contract. Highlights an 89% Physical, 1% Hybrid, and 10% Remote job distribution, with an average salary of $142,920 per year, or $68.7 per hour.

Director, Medical Device Interface, Regulatory Affairs

Jj

Raritan, NJ

$153K - $202K/yr

Full-time

Retirement, PTO

Posted 10 days ago

Job description

At Johnson & Johnson,we believe health is everything. Our strength in healthcare innovation empowers us to build aworld where complex diseases are prevented, treated, and cured,where treatments are smarter and less invasive, andsolutions are personal.Through our expertise in Innovative Medicine and MedTech, we are uniquely positioned to innovate across the full spectrum of healthcare solutions today to deliver the breakthroughs of tomorrow, and profoundly impact health for humanity.Learn more at jnj.com

As guided by Our Credo, Johnson & Johnson is responsible to our employees who work with us throughout the world. We provide an inclusive work environment where each person is considered as an individual. At Johnson & Johnson, we respect the diversity and dignity of our employees and recognize their merit.

Job Function:

Discovery & Pre-Clinical/Clinical Development

Job Sub Function:

Regulatory Science

Job Category:

Scientific/Technology

All Job Posting Locations:

Allschwil, Basel-Country, Switzerland, Beerse, Antwerp, Belgium, Raritan, New Jersey, United States of America

Job Description:

About Innovative Medicine

Our expertise in Innovative Medicine is informed and inspired by patients, whose insights fuel our science-based advancements. Visionaries like you work on teams that save lives by developing the medicines of tomorrow.

Join us in developing treatments, finding cures, and pioneering the path from lab to life while championing patients every step of the way.

Learn more at https://www.jnj.com/innovative-medicine

We are searching for the best talent for Director, Medical Device Interface, Regulatory Affairs.

Please note that this role is available across multiple countries and may be posted under different requisition numbers to comply with local requirements. While you are welcome to apply to any or all of the postings, we recommend focusing on the specific country(s) that align with your preferred location(s):

United States - Requisition Number: R-092015

Belgium - Requisition Number: R-092902

Switzerland - Requisition Number: R-092905

Remember, whether you apply to one or all of these requisition numbers, your applications will be considered as a single submission.

Purpose: Johnson & Johnson Innovative Medicine R&D is recruiting a Director, Medical Device Interface, Regulatory Affairs to provide strategic regulatory leadership for medical devices used in medicinal product development, including investigational devices supporting global clinical programs. We are seeking a hands-on leader who is comfortable diving into details while also shaping scalable approaches that support long-term portfolio and organizational goals.

This role serves as a regulatory and clinical medical device subject matter expert, working across all JJIM therapeutic areas with an initial focus on supporting novel oncology programs. The position requires deep global expertise in medical device regulations, particularly investigational devices, combined with a strong working knowledge of drug development processes. The successful candidate will lead global regulatory strategies for the device component of clinical programs, contribute to the development of infrastructure for investigational device processes and drive the execution of these strategies and related filings while partnering across Regulatory Affairs, Clinical, R&D, Quality, and other functions.

You will be responsible for:

  • Leading medical device aspects of development programs and device activities; guiding and directing the team on the requirements to fulfil investigational and non-investigational device requirements.
  • Providing leadership and regulatory direction to drive device infrastructure and business strategy decisions
  • Providing support and inputs for quality system processes related to investigational devices, regulatory procedures, investigational device applications
  • Driving global regulatory strategies for devices used in clinical development, ensuring alignment with overall drug regulatory strategies.
  • Defining and driving filing strategies for investigational device submissions, including IDEs, Clinical Investigation Applications (CIAs), and support device components of IND and CTA submissions.
  • Preparing, reviewing, and executing regulatory submissions and supporting evidence packages, directly or through management of CROs, vendors, or external partners.
  • Providing regulatory oversight for clinical trial-related device labeling and documentation, including Instructions for Use (IFU), investigator materials, and associated records.
  • Ensuring compliance with applicable global device regulations and standards, including EU MDR, national competent authority requirements, FDA expectations, design controls, risk management, human factors/usability considerations, and other regional requirements.
  • Identifying, assessing, and proactively managing regulatory risks associated with device development and clinical investigations.

Regulatory Strategy, Agency Interactions & Submission Execution

  • Preparing for and driving and/or supporting interactions with Health Authorities on device-related matters, including development of briefing materials and responses to agency questions.
  • Ensuring clinical protocols and development plans align with applicable device regulatory requirements.
  • Providing regulatory support throughout development, clinical investigation, registration, lifecycle management, inspections, audits, litigation support, and product complaint activities.
  • Advising teams on required device documentation, submission content, and filing strategies in collaboration with Local Operating Companies (LOCs) and global stakeholders.
  • Coordinating regulatory activities to ensure timely submission readiness, tracking critical path activities and key milestones.
  • Supporting preparation, submission, acceptance, and maintenance of regulatory filings, including INDs, CTAs, CIAs, MAAs, IDEs for device related information.
  • Liaising with LOCs to ensure country-specific submission packages are delivered according to agreed timelines and to track submissions and authority responses.
  • Representing teams in interactions with regulatory agencies, including organizing and leading meetings with specific device content where required.
  • Supporting Global Regulatory Leads through project management, planning, and execution of major regulatory submissions and Health Authority interactions.
  • Participating in global regulatory team meetings and contribute to the development and continuous improvement of device and investigational-device regulatory QMS processes.
  • Partnering with regulatory colleagues to monitor the competitive and evolving device regulatory landscape, including agency perspectives, precedents, labeling practices, and disease-area-specific considerations.

Qualifications & Requirements:

  • Education: Minimum of a Bachelor's degree in a scientific or related discipline plus a minimum of 10 years of experience in a regulated healthcare industry is required

Skills/Experience:

  • Strong regulatory affairs expertise in medical devices, including in-depth knowledge of EU device regulations and broad understanding of global device regulatory framework is required.
  • Demonstrated experience supporting device development, supporting device clinical investigations, and other device-related regulatory submissions is required.
  • Both hands-on experience with EU clinical investigational device submission systems and direct, practical involvement in preparing or owning key components of CIA applications is required.
  • Strong regulatory knowledge in device development and submissions, including IDEs, CIAs, ITAs, and marketing applications for devices (ex. 510(k), De Novo, CE mark), lifecycle management activities is preferred.
  • Experience supporting combination products and programs integrating device and pharmaceutical/biologic development is strongly preferred.
  • Experience preparing regulatory submission content, supporting Health Authority interactions, and leading cross-functional regulatory planning is required.
  • Strong understanding of global regulatory requirements and experience operating effectively within matrixed, multinational organizations is required.
  • Oncology experience is desirable.
  • Experience in strategic planning, technical data summarization, and cross-functional project leadership is required.
  • Intellectual curiosity, learning agility, and adaptability to work in emerging areas where regulatory precedent may be limited and across multiple product modalities, including pharmaceuticals, devices, and combination products.

Johnson & Johnson is an Equal Opportunity Employer. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, age, national origin, disability, protected veteran status or other characteristics protected by federal, state or local law. We actively seek qualified candidates who are protected veterans and individuals with disabilities as defined under VEVRAA and Section 503 of the Rehabilitation Act.

Johnson & Johnson is committed to providing an interview process that is inclusive of our applicants' needs. If you are an individual with a disability and would like to request an accommodation, external applicants please contact us via https://www.jnj.com/contact-us/careers , internal employees contact AskGS to be directed to your accommodation resource.

If you are under 18 years of age you (the candidate) may need to obtain the necessary working papers or other documentation required by state law to start the assignment, as well as get a parent's consent for the background check.

#LI-Hybrid

Required Skills:

Preferred Skills:

Consulting, Corporate Governance, Design Mindset, Drug Discovery Development, Fact-Based Decision Making, Healthcare Trends, Interpersonal Influence, Mentorship, Public Policies, Regulatory Affairs Management, Regulatory Compliance, Regulatory Development, Regulatory Environment, Scientific Research, Stakeholder Management, Strategic Thinking, Technical Writing

The anticipated base pay range for this position is :

$164,000.00 - $282,900.00

Additional Description for Pay Transparency:

Subject to the terms of their respective plans, employees are eligible to participate in the Company's consolidated retirement plan (pension) and savings plan (401(k)).
This position is eligible to participate in the Company's long-term incentive program.
Subject to the terms of their respective policies and date of hire, employees are eligible for the following time off benefits:
Vacation -120 hours per calendar year
Sick time - 40 hours per calendar year; for employees who reside in the State of Colorado -48 hours per calendar year; for employees who reside in the State of Washington -56 hours per calendar year
Holiday pay, including Floating Holidays -13 days per calendar year
Work, Personal and Family Time - up to 40 hours per calendar year
Parental Leave - 480 hours within one year of the birth/adoption/foster care of a child
Bereavement Leave - 240 hours for an immediate family member: 40 hours for an extended family member per calendar year
Caregiver Leave - 80 hours in a 52-week rolling period10 days
Volunteer Leave - 32 hours per calendar year
Military Spouse Time-Off - 80 hours per calendar year
For additional general information on Company benefits, please go to: - https://www.careers.jnj.com/employee-benefits

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