Job Description

We are currently seeking a **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 **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) is required; preferably in a scientific or equivalent technical discipline + Minimum 6 years of experience working in Regulatory Affairs + Minimum 8 years of experience in an FDA regulated industry + Minimum 1 year of managerial/supervisory experience + Demonstrated 510(k), PMA organization, preparation, and review experience + Demonstrated experience in interacting with FDA review staff and inspectors, Notified Bodies and international reviewers/inspectors + Demonstrated ability to lead diverse team and team members in remote locations **Preferred** + Master's Degree or equivalent + Regulatory Affairs Certification $138,700.00 - $226,900.00 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.

Job Tags

Temporary work, Remote work, Flexible hours,

Similar Jobs