Job Description

Stryker is seeing a **Regulatory Compliance Specialist** for our Endoscopy ( division. This is a remote role located anywhere within the US. **What you will do** As the **Regulatory Compliance Specialist,** you will support post-market regulatory activities that ensure the safety and effectiveness of our products in the field. + Support assessments and documentation for product field actions and commercial holds + Review and analyze post-market data to identify trends and potential issues + Collaborate with cross-functional teams to develop and implement quality improvements + Assist in preparing reports and summaries for internal and external stakeholders + Communicate directly with customers and regulatory agencies regarding reported complaints and resolutions + Participate in complaint handling and adverse event reporting processes + Contribute to internal audits and regulatory inspections + Use sound judgment to identify areas for improvement and support corrective actions **What you need** **Required** + Bachelor's degree in Science, Engineering, or related field + 0-2 years of experience in a regulated manufacturing environment + Strong analytical and problem-solving skills + Ability to manage multiple tasks and meet deadlines **Preferred** + Familiarity with post-market regulatory activities, including product field actions and product holds + Knowledge of FDA and international medical device regulations (e.g., 21 CFR Part 803, 21 CFR Part 820, ISO 13485) + Experience with MDR/MIR reporting + Exposure to cross-functional collaboration in a quality or regulatory setting $69,100 - $139,600 salary plus bonus eligible + benefits. 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, Work at office, Remote work, Flexible hours,

Similar Jobs