Senior Manager, Regulatory Affairs, Mako and Enabling Technologies

Stryker; Fort Lauderdale (FL); Hybrid; USD 129,000 - 287,000; Full time

Job summary

Join a forward-thinking company as a Senior Manager in Regulatory Affairs, where you'll lead global regulatory strategies and ensure compliance for innovative medical devices. This role offers the chance to collaborate across various divisions and contribute to high-impact product launches. With a focus on team leadership and cross-functional alignment, you'll play a vital role in shaping the future of healthcare technology. If you're passionate about regulatory affairs and looking to make a significant impact, this position is perfect for you.

Benefits

Medical and prescription drug insurance

Dental insurance

Vision insurance

401(k) plan

Employee Stock Purchase Plan (ESPP)

Health Savings Account (HSA)

Flexible Spending Accounts (FSAs)

Short-term disability insurance

Wellbeing program

Tobacco cessation program

Qualifications

• 10+ years in an FDA regulated industry with managerial experience.
• Strong understanding of global medical device regulations.

Responsibilities

• Lead global regulatory activities for product launches and market access.
• Develop regulatory strategies and maintain internal documentation.

Skills

Regulatory Affairs

Team Leadership

Global Medical Device Regulations

Cross-functional Collaboration

Education

Bachelor’s degree (B.S. or B.A.)

Tools

Regulatory Submissions

Job description

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

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.

Health benefits include : Medical and prescription drug insurance, dental insurance, vision insurance, critical illness insurance, accident insurance, hospital indemnity insurance, personalized healthcare support, wellbeing program and tobacco cessation program. Financial benefits include : Health Savings Account (HSA), Flexible Spending Accounts (FSAs), 401(k) plan, Employee Stock Purchase Plan (ESPP), basic life and AD&D insurance, and short-term disability insurance. Stryker offers innovative products and services in MedSurg, Neurotechnology, Orthopaedics and Spine that help improve patient and healthcare outcomes. Alongside its customers around the world, Stryker impacts more than 150 million patients annually. Depending on customer requirements employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required to obtain various vaccinations as an essential function of their role.

Stryker Corporation is an equal opportunity employer. Qualified applicants will receive consideration for employment without regard to race, ethnicity, color, religion, sex, gender identity, sexual orientation, national origin, disability, or protected veteran status. Stryker is an EO employer – M / F / Veteran / Disability.

Create a job alert for this search

Senior Manager Regulatory • Fort Lauderdale, FL, United States