Senior Manager, Regulatory Affairs, Mako and Enabling Technologies

We are currently seeking a Senior Manager, Regulatory Affairs to join our Joint Replacement Division (Mako and Enabling Technologies Business Unit). Ideally, this role will be hybrid in Mahwah, NJ or Weston, FL with some workplace flexibility.

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 and/or software devices for various orthopedic applications and provides unique opportunities to collaborate across various Stryker divisions. 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

What you need 

Required

• 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

Preferred

• Master’s degree

• RAC Certification

• Strong technical knowledge of medical device products

$129,600.00 - $286,500.00 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.