Senior Manager, Regulatory Affairs, Mako and Enabling Technologies
Attention all experienced regulatory affairs professionals! Are you ready to take your career to the next level with a dynamic and innovative medical technology company? Stryker is seeking a Senior Manager to lead our Regulatory Affairs team for our Mako and Enabling Technologies division. In this role, you will have the opportunity to make a significant impact on the development and commercialization of cutting-edge medical devices that improve patient outcomes. We are looking for a highly motivated individual with a strong background in regulatory affairs and leadership experience to join our team. If you are passionate about driving success and bringing new technologies to market, we want to hear from you!
- Lead and manage the Regulatory Affairs team for the Mako and Enabling Technologies division at Stryker.
- Develop and implement strategic plans for regulatory approvals and submissions for new and existing medical devices.
- Ensure compliance with all relevant regulations and standards, including FDA, EU MDR, and ISO.
- Stay up-to-date on changes and updates in regulations and communicate any potential impact to the company.
- Collaborate with cross-functional teams to ensure regulatory requirements are considered and addressed in all aspects of product development and commercialization.
- Provide guidance and support to the development team regarding regulatory requirements and potential roadblocks.
- Prepare and submit regulatory filings, including IDEs, PMAs, 510(k)s, and CE Mark applications.
- Manage relationships with regulatory agencies and act as the primary point of contact for all regulatory matters.
- Ensure timely and accurate completion of all regulatory deliverables, including submission timelines and responses to agency questions.
- Mentor and develop team members, providing support and guidance for their professional growth and success.
- Drive continuous improvement initiatives and implement best practices to streamline regulatory processes.
- Collaborate with other departments, such as Quality Assurance, Clinical Affairs, and Marketing, to ensure alignment and consistency in regulatory strategy.
- Represent Stryker in industry forums and conferences, staying informed on industry trends and best practices.
- Monitor and report on regulatory metrics and provide updates to senior management on the status of regulatory affairs activities.
- Demonstrate a strong commitment to patient safety and ethical standards in all regulatory activities.
Extensive Experience In Regulatory Affairs: The Ideal Candidate Should Have A Minimum Of 10 Years Of Experience In Regulatory Affairs, Preferably In The Medical Device Industry. They Should Be Well-Versed In Global Regulatory Requirements And Have A Strong Track Record Of Successful Regulatory Submissions.
In-Depth Knowledge Of Mako And Enabling Technologies: Stryker's Mako And Enabling Technologies Are Cutting-Edge Medical Devices And The Senior Manager Of Regulatory Affairs Should Have A Thorough Understanding Of Their Design, Development, And Regulatory Requirements. Previous Experience Working With These Technologies Would Be Highly Desirable.
Strong Leadership Skills: As A Senior Manager, This Role Will Involve Leading A Team Of Regulatory Professionals. The Ideal Candidate Should Have Excellent Leadership Skills, Including The Ability To Mentor And Develop Team Members, Delegate Tasks Effectively, And Drive Results.
Strategic Thinking And Problem-Solving Abilities: The Senior Manager Will Be Responsible For Developing Regulatory Strategies And Resolving Complex Regulatory Issues. They Should Have Strong Analytical Skills, Be Able To Think Strategically, And Have The Ability To Develop Creative Solutions To Regulatory Challenges.
Excellent Communication And Interpersonal Skills: This Role Requires Collaboration With Various Internal And External Stakeholders, Including Cross-Functional Teams, Regulatory Authorities, And Other Industry Professionals. The Senior Manager Should Have Excellent Communication And Interpersonal Skills To Effectively Convey Complex Regulatory Information And Build Strong Relationships.
Risk Management
Quality Assurance
Strategic Planning
Project Management
Clinical Research
Budget management
Technical Writing
Team Leadership
Regulatory compliance
Cross-Functional Collaboration
Regulatory
Product Registration
Communication
Conflict Resolution
Emotional Intelligence
Leadership
Time management
creativity
Teamwork
Active Listening
Adaptability
Problem-Solving
According to JobzMall, the average salary range for a Senior Manager, Regulatory Affairs, Mako and Enabling Technologies in Mahwah, NJ 07430, USA is between $130,000 and $170,000 per year. This may vary depending on the specific company, level of experience, and other factors.
Apply with Video Cover Letter Add a warm greeting to your application and stand out!
Stryker Corp. is engaged in providing medical technology products and services. It operates through the following segments: Orthopaedics, MedSurg and Neurotechnology and Spine. The Orthopaedics segment provides reconstructive and trauma implant systems. The Medsurg segment deals with surgical instruments and equipment, endoscopy, patient handling, and reprocessed medical devices. The Neurotechnology and Spine segment pertains to spinal implants and neurovascular products.
Get interviewed today!
JobzMall is the world‘ s largest video talent marketplace.It‘s ultrafast, fun, and human.
Get Started