Sr. Director, Regulatory Affairs
Sr. Director, Regulatory Affairs

Sr. Director, Regulatory Affairs

Full-Time 117000 - 186000 £ / year (est.) No home office possible
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At a Glance

  • Tasks: Lead regulatory strategy for innovative surgical robotics and ensure compliance with quality systems.
  • Company: Join Sysmex, a global leader in diagnostic equipment, dedicated to improving lives through innovation.
  • Benefits: Enjoy competitive salary, health plans, paid time off, and a supportive work environment.
  • Why this job: Be part of a dynamic team making impactful advancements in medical technology and patient care.
  • Qualifications: 15+ years in medical devices with strong knowledge of FDA regulations; advanced degree preferred.
  • Other info: Opportunity for travel and collaboration with international teams in a fast-paced setting.

The predicted salary is between 117000 - 186000 £ per year.


Sr. Director, Regulatory Affairs

Job Location(s)

US-IL-Lincolnshire

# of Openings 1 Job ID 2024-4181 Category Surgical Robotics Business Travel 25%


Overview

Find a Better Way…

…to use your skills and experience.

This is the time to let your talent come to life. To maximize your knowledge and use it for the greater good. To work with the best professionals using state-of-the-art technology, and improve lives with your innovative ideas and ambitious dreams. Find a better way: the Sysmex Way.

…to improve the lives of others.

Headquartered in Kobe, Japan, Sysmex is located in Lincolnshire, Illinois. Renowned worldwide for the very finest in quality, innovative diagnostic equipment and information-management systems, we apply science to enhance the quality of life on a global scale. Our agile, resourceful team is committed to realizing critical breakthroughs in laboratory diagnostics, information technology, workflow analysis and life sciences for the clinical laboratory.

…to build a promising future.


Responsibilities

We currently have a great opportunity available for a Regulatory Affairs Sr. Director. The Sr Director of Regulatory leads the organization in developing the Americas regulatory strategy for Robot Assisted Surgical (RAS) system, instruments, and accessories for minimally invasive surgical procedures. This individual will collaborate with our partners at Medicaroid Japan along with the SAI Clinical and Quality teams to bring RAS medical devices to market through the Americas Clinical and regulatory framework while ensuring compliance of the quality system.

Essential Duties and Responsibilities:

1. Identify, assess, and communicate regulatory development, submission strategies, and interface with relevant regulatory authorities.
2. Responsible for directing the preparation, documentation and submission of regulatory applications and providing responses to regulatory agencies regarding device information or issues. Includes the summary of data collected and demonstration of acceptable performance.
3. Review all regulatory materials to guarantee accuracy, timeliness, comprehensiveness, and compliance with regulatory standards.
4. Provide regulatory guidance to departments or development project teams regarding design, development, evaluation, or marketing of products.
5. Support project teams through development of regulatory strategies that meet regulatory requirements and provide guidance regarding regulatory requirements for planned changes.
6. Maintain current knowledge of relevant regulations and guidelines, both proposed and final rules.
7. Ensure understanding of risk and approximate timing for approvals for planning purposes.
8. Support post-market products through change evaluation and submission and annual reporting as required.
9. Provide input on appropriate pre-clinical, usability, and clinical study protocols to accurately assess the safety and efficacy of RAS products, instruments, and accessories.
10. Other duties as assigned

Percentage of Travel: Ability to travel up to 25%, domestic and international.

Physical Risk: Regular exposures to risk that may require special training and precautions.

Physical Demands: Light physical effort. Routine handling of objects up to 20 pounds; prolonged (at least 50% of time) sitting, standing, keyboard or CRT work. May require periods of moderate discomfort due to noise, dust, lighting and/or other conditions.


Qualifications

    Bachelor\’s degree with 15+ years of experience preferably in medical devices, surgical devices or surgical environment including Sr. management experience. Master\’s degree preferred. Robot Assisted Surgical Devices experience preferred.
  • RAPs certification a Plus
  • Strong working knowledge of FDA Regulations around 21 CFR 876.1500, ICH Guidelines and GCPs governing the conduct of clinical trials.
  • Proficient in Microsoft Office
  • Strong written and verbal communication skills
  • Resourceful and ability to take initiative in a fast-paced, dynamic organization.

The salary range for this role is $156,740.50 – $246,306.50. Within this range, individual pay is determined by work location and additional factors, including job-related skills, experience, and relevant education or training. The total compensation package for this position also includes a choice of health care plan (medical, vision, and dental insurance), an annual incentive bonus, paid time off, parental leave, bereavement leave and a 401(K) for all eligible employees.

Sysmex is proud to be an EEO/Affirmative Action employer. All qualified applicants will receive consideration for employment and will not be discriminated against on the basis of race, age, sex, sexual orientation, gender identity or expression, color, religion, national origin, genetics, disability status, protected veteran status or any other characteristic protected by law. We maintain a drug-free workplace and perform pre-employment substance abuse testing.

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Sr. Director, Regulatory Affairs employer: Sysmex America, Inc

Sysmex is an exceptional employer located in Lincolnshire, Illinois, offering a dynamic work culture that fosters innovation and collaboration among top professionals in the field of surgical robotics. With a strong commitment to employee growth, Sysmex provides comprehensive benefits including health care plans, annual bonuses, and generous paid time off, ensuring that team members can thrive both personally and professionally while contributing to meaningful advancements in healthcare technology.
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Contact Detail:

Sysmex America, Inc Recruiting Team

StudySmarter Expert Advice 🤫

We think this is how you could land Sr. Director, Regulatory Affairs

✨Tip Number 1

Network with professionals in the regulatory affairs field, especially those with experience in medical devices and surgical environments. Attend industry conferences or webinars to connect with potential colleagues and learn about the latest trends and challenges in regulatory strategies.

✨Tip Number 2

Familiarise yourself with the specific regulations and guidelines relevant to Robot Assisted Surgical Devices. Understanding the nuances of FDA Regulations around 21 CFR 876.1500 and ICH Guidelines will give you an edge in discussions during interviews.

✨Tip Number 3

Prepare to discuss your previous experiences in leading regulatory submissions and your approach to compliance. Highlight any successful projects where you navigated complex regulatory landscapes, as this will demonstrate your capability for the Sr. Director role.

✨Tip Number 4

Showcase your leadership skills by discussing how you've guided teams through regulatory processes in the past. Be ready to provide examples of how you’ve collaborated with cross-functional teams to achieve regulatory goals, as this is crucial for the position.

We think you need these skills to ace Sr. Director, Regulatory Affairs

Regulatory Strategy Development
Knowledge of FDA Regulations (21 CFR 876.1500)
Clinical Trial Guidelines (ICH and GCP)
Regulatory Submission Preparation
Risk Assessment and Management
Cross-Functional Collaboration
Project Management
Strong Written and Verbal Communication Skills
Attention to Detail
Ability to Work in a Fast-Paced Environment
Experience with Robot Assisted Surgical Devices
Proficiency in Microsoft Office
Leadership and Team Management
Problem-Solving Skills

Some tips for your application 🫡

Tailor Your CV: Make sure your CV highlights relevant experience in regulatory affairs, particularly in the medical devices or surgical environment. Emphasise your leadership roles and any specific achievements related to regulatory submissions.

Craft a Compelling Cover Letter: In your cover letter, express your passion for improving lives through innovative medical technology. Mention your understanding of FDA regulations and how your experience aligns with the responsibilities outlined in the job description.

Showcase Relevant Skills: Highlight your strong written and verbal communication skills, as well as your ability to work in a fast-paced environment. Provide examples of how you've successfully navigated regulatory challenges in previous roles.

Research Sysmex: Familiarise yourself with Sysmex's mission and values. Understanding their commitment to quality and innovation will help you align your application with their goals and demonstrate your enthusiasm for the role.

How to prepare for a job interview at Sysmex America, Inc

✨Understand Regulatory Frameworks

Familiarise yourself with the specific regulatory frameworks relevant to Robot Assisted Surgical devices. Be prepared to discuss how your experience aligns with FDA regulations and ICH guidelines, as this will demonstrate your expertise in navigating complex regulatory environments.

✨Showcase Leadership Experience

As a Sr. Director, you'll need to exhibit strong leadership skills. Prepare examples of how you've successfully led teams in previous roles, particularly in regulatory affairs or medical device sectors, to highlight your ability to guide projects through compliance challenges.

✨Prepare for Technical Questions

Expect technical questions related to regulatory submissions and compliance processes. Brush up on your knowledge of 21 CFR 876.1500 and be ready to explain how you would approach the preparation and submission of regulatory applications.

✨Demonstrate Communication Skills

Effective communication is key in regulatory affairs. Be ready to provide examples of how you've communicated complex regulatory information to various stakeholders, ensuring clarity and understanding across departments.

Sr. Director, Regulatory Affairs
Sysmex America, Inc
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  • Sr. Director, Regulatory Affairs

    Full-Time
    117000 - 186000 £ / year (est.)

    Application deadline: 2027-07-14

  • S

    Sysmex America, Inc

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