Associate Manager, Regulatory Affairs

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.