[Hiring] Senior Manager, Regulatory Affairs, Mako and Enabling Technologies @Stryker Employment Company, LLC
Apr 15, 2025 - Stryker Employment Company, LLC is hiring a remote Senior Manager, Regulatory Affairs, Mako and Enabling Technologies. 💸 Salary: $155,500.00 - $264,500.00 usd salary plus bonus eligible + benefits. 📍Location: USA.
Role Description
We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). This is a hybrid position based in Mahwah, NJ or Weston, FL.
As the Senior Manager, Regulatory Affairs, you will lead and coordinate global regulatory activities including:
- Regulatory strategies and health authority submissions to support high impact new product launches
- Ongoing market access and total product life cycle
You will oversee Joint Replacement's Mako and Enabling Technologies portfolio, which includes:
- Robotics
- Navigation
- Capital equipment
- Imaging technology
- Software devices for various orthopedic applications
You will confidently and collaboratively work across the RA teams and cross-functional partners, as well as with individuals across international locations and time zones, cultures, and languages to support global sales growth. You will devote a significant portion of time to:
- Managerial, leadership and employee development responsibilities
- Ensuring strategic oversight and cross-functional alignment to meet regulatory requirements
What you will do:
- Direct and coordinate activities of experienced Regulatory Affairs professionals to support total product life cycle
- Develop and implement regulatory strategies for preparation and submission of regulatory applications and maintenance of internal regulatory file documentation
- Collaborate across Stryker divisions and international teams to drive global sales growth
- Provide strategic oversight and ensure cross-functional alignment to meet regulatory requirements
- Recruit, hire, train, manage, develop and motivate Regulatory Affairs staff
- Ensure that departmental Standard Operating Procedures (SOP's) are developed, implemented, and maintained
- Lead communications with health care authorities (e.g. FDA and EU Notified Bodies) and direct health authority interactions with internal teams
- Ensure quality and compliance of regulatory submissions, labeling, and marketing materials
- Communicate and collaborate with Quality Assurance, R&D, Service, Global Supply, Finance, Sales, and Marketing departments to ensure corporate goals and strategies are met
Qualifications
- Bachelor’s degree (B.S. or B.A.)
- 10+ years of work experience in an FDA regulated industry
- 2-3+ years of managerial/supervisory experience
- Understanding of global medical device regulations including direct experience with regulatory submissions associated with US and EU Class II/III medical devices
- Ability to lead a team, collaborate effectively at cross-functional levels, influence others and handle increasing levels of responsibilities
Requirements
- Preferred Master’s degree
- RAC Certification
- Strong technical knowledge of medical device products
Benefits
- $155,500.00 - $264,500.00 USD salary plus bonus eligible + benefits
- Actual minimum and maximum may vary based on location
- Individual pay is based on skills, experience, and other relevant factors
- Travel Percentage: 20%
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| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
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Salary
💸
$155,500.00 - $264,500.00 usd salary plus bonus eligible + benefits
|
Remote
Location
USA
|
|
Job Type
full-time
|
Posted
Apr 15, 2025
|
| 📍 | Be aware of the location restriction for this remote position: USA |
| ‼ | Beware of scams! When applying for jobs, you should NEVER have to pay anything. Learn more. |
