Job Description

Stryker is hiring an **Associate Manager, Regulatory Affairs** preferrable in **Portage, MI,** to join our **Craniomaxillofacial (CMF)** **Business!** In this role, you will lead and manage a team of regulatory professionals to ensure compliance with applicable regulatory requirements at the local, state, and federal levels. You will drive the implementation of these regulations to ensure ongoing compliance. **Work Flexibility** : Remote, hybrid, or onsite. It is strongly preferred that the candidate be based within a commuting distance of **Portage, MI.** **Travel:** The selected candidate should be comfortable traveling once a quarter. **Key areas of responsibility** + Lead teams to support regulatory processes for market access of products + Manage budget, if appropriate + May lead the development of new systems and procedures + Plans, conduct, and supervise assignments + Reviews progress and evaluate results + Support continuous improvement activities + Define targets, KPIs, performance objectives, etc. for individuals within functional role, and manage direct reports to meet or exceed these targets + Recruit and onboard top talent, develop team capabilities, proactively manage performance, and foster high team engagement + Participates in advocacy activities of a technical audit/nature **What you need:** Required: + Bachelor's degree required. Preferred degree in a science, engineering, or related field. + 6+ years of regulatory experience. Preferred: + Master's Degree or RAC preferred + Previous supervisory experience preferred + Experience with Class III Premarket Approval devices is highly desirable + Familiarity with European medical device regulations + Regulatory Affairs experience within Medical Device preferred + Demonstrated knowledge and application of regulatory requirements, including ISO, FDA, and international requirements + Demonstrate technical knowledge of medical devices, tissues, and/or drug product lines + Strong communication, team building, and leadership skills + Proven ability to lead cross-functional teams, manage multiple projects, and drive process improvements + Experience mentoring interns, interviewing candidates, recruiting, and coaching and developing team members preferred + Understanding of scientific and health concepts $100,500- $210,000 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, Local area, Remote work, Flexible hours,

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