Current jobs related to Staff Specialist, Adverse Event Reporting Divisional Process Owner - Portage - Stryker

  • Freelance Event Specialist

    2 months ago

    Portage, United States visit.org Full time

    Visit.org is looking for an experienced, responsible, and driven Freelance Event Specialist in Portage, MI to help us manage the logistics of an upcoming in-person event, which will be held live at a city near you! The right candidate will have an entrepreneurial spirit, love of live events, extreme passion for our mission, and the energy and discipline to...

  • Freelance Event Specialist

    4 months ago

    Portage, United States visit.org Full time

    Visit.org is looking for an experienced, responsible, and driven Freelance Event Specialist in Battle Creek, MI to help us manage the logistics of an upcoming in-person event, which will be held live at a city near you! The right candidate will have an entrepreneurial spirit, love of live events, extreme passion for our mission, and the energy and discipline...

  • Entrepreneurial Agency Owner

    7 days ago

    Portage, Michigan, United States AAA-The Auto Club Group Full time

    Unlock Your Potential as an Entrepreneurial Agency OwnerAt AAA - The Auto Club Group, we're seeking ambitious and visionary business leaders to join our team as Entrepreneurial Agency Owners. This is an exceptional opportunity to build a profitable, multi-line insurance agency and serve new and prospective AAA Members.Key Responsibilities:Sell property and...

  • Entrepreneurial Agency Owner

    7 days ago

    Portage, Michigan, United States AAA-The Auto Club Group Full time

    Unlock Your Potential as an Entrepreneurial Agency OwnerAt AAA - The Auto Club Group, we're seeking ambitious and visionary business leaders to join our team as Entrepreneurial Agency Owners. This is an exceptional opportunity to build a profitable, multi-line insurance agency and serve new and prospective AAA Members.Compensation PackageWe offer one of the...

  • Entrepreneurial Agency Owner

    7 days ago

    Portage, Michigan, United States AAA-The Auto Club Group Full time

    Unlock Your Potential as an Entrepreneurial Agency OwnerAt AAA - The Auto Club Group, we're seeking ambitious and visionary business leaders to join our team as Entrepreneurial Agency Owners. This is an exceptional opportunity to build a profitable, multi-line insurance agency and serve new and prospective AAA Members.Compensation PackageWe offer one of the...

  • Marketing Operations Specialist

    1 month ago

    Portage, United States The Kendall Group Full time

    Marketing Operations SpecialistAbout The Kendall GroupThe Kendall Group seeks a talented, creative, self-motivated individual for our Marketing Operations Specialist position. The Kendall Group is comprised of seven divisions with 75+ locations in eleven states. Combined, we serve the Electrical, Automation, Pipe, Valve, and Fittings products, Steam,...

  • Independent Event Coordinator

    4 weeks ago

    Portage, Michigan, United States visit Full time

    Position Overview:We are seeking a dedicated and skilled Freelance Event Specialist to assist in orchestrating the logistics of an upcoming in-person gathering. The ideal candidate will possess a strong entrepreneurial mindset, a passion for live events, and the enthusiasm to create a memorable experience for participants.Our Mission:We believe in empowering...

  • Marketing Operations Specialist

    4 weeks ago

    Portage, United States The Kendall Group Full time

    Marketing Operations Specialist About The Kendall Group The Kendall Group seeks a talented, creative, self-motivated individual for our Marketing Operations Specialist position. The Kendall Group is comprised of seven divisions with 75+ locations in eleven states. Combined, we serve the Electrical, Automation, Pipe, Valve, and Fittings products, Steam,...

  • Manufacturing Process Specialist

    4 weeks ago

    Portage, Michigan, United States Avero Full time

    Avero is on the lookout for a talented Manufacturing Process Specialist to enhance our operational efficiency. Experience: 3-5 years in process optimization within the manufacturing sector, with a focus on the paper industry.Skills: Expertise in statistical analysis techniques and control processes.Achievements: Proven track record in executing continuous...

  • Process Engineer

    1 week ago

    Portage, Wisconsin, United States Milliken & Company Full time

    Job Title: Process Engineer - Commercialization SpecialistMilliken & Company is seeking a highly skilled Process Engineer - Commercialization Specialist to join our team. As a key member of our commercialization team, you will be responsible for scaling up new chemical encapsulation products, validating new equipment and processes, and serving as a technical...

  • Retail Staff Pharmacist

    2 months ago

    Portage, United States The Hometown Pharmacy Full time

    Description Part-time Pharmacist opportunity. Averaging 8-14 hours weekly. Interested in joining a team of professionals delivering patients innovated and trusted health and wellness care that thrive on making an impact in local communities and not only support but encourage a healthy work/life balance. Then consider a career at Hometown Pharmacies and join...

  • Technical Support Specialist

    2 weeks ago

    Portage, Michigan, United States Rose International Full time

    Job SummaryRose International is seeking a highly skilled Technical Support Specialist to join our team. As a Technical Support Specialist, you will be responsible for providing technical support to engineers and scientists on a variety of technical tasks.Key ResponsibilitiesDevelop and recommend procedures and methods for technical tasks.Prepare technical...

  • Financial Reporting Specialist

    3 weeks ago

    Portage, Michigan, United States iMPact Business Group Full time

    Job Opportunity: We are seeking a highly skilled Accounting Analyst to join our team at iMPact Business Group.About the Role:As an Accounting Analyst, you will be responsible for providing financial analysis and reporting to support business decisions.You will work closely with our finance team to ensure accurate and timely financial reporting.Develop and...

  • Senior Staff Accountant

    4 months ago

    Portage, United States International Electrical Testing Association Full time

    Job DescriptionJob DescriptionPosition Summary:The Senior Staff Accountant will play a crucial role in ensuring the accuracy and integrity of financial data, analyzing financial information, and preparing financial reports. This position requires a detail-oriented individual with strong analytical skills and a deep understanding of accounting principles. The...

  • Retail Staff Pharmacist

    2 months ago

    Portage, United States The Hometown Pharmacy Full time

    Description Part-time Pharmacist opportunity. Averaging 8-14 hours weekly. Interested in joining a team of professionals delivering patients innovated and trusted health and wellness care that thrive on making an impact in local communities and not only support but encourage a healthy work/life balance. Then consider a career at Hometown Pharmacies and join...

  • Process Improvement Specialist

    3 weeks ago

    Portage, Indiana, United States The Judge Group Full time

    About The Judge GroupThe Judge Group is a leading provider of professional staffing services, specializing in the placement of accounting, finance, and technology professionals.Job DescriptionWe are seeking a highly skilled Continuous Improvement Engineer to join our team. As a key member of our operations team, you will play a critical role in driving...

  • Nurse Specialist

    7 days ago

    Portage, Wisconsin, United States Staff Today Full time

    Job Title: Registered Nurse - Correctional SettingStaff Today is seeking a skilled Registered Nurse to join our team in a correctional facility in Portage, Wisconsin.Job Summary:We are looking for a dedicated and compassionate Registered Nurse to provide high-quality patient care in a correctional setting. The ideal candidate will have experience working in...

  • Advanced Quality Assurance Specialist

    4 hours ago

    Portage, Indiana, United States Ursitti Enterprises LLC Full time

    Job SummaryUrsitti Enterprises LLC is seeking an experienced Advanced Quality Assurance Specialist to join our team at our Portage facility. As a key member of our quality assurance team, you will be responsible for leading the development, implementation, and maintenance of quality systems that support manufacturing operations.Key Responsibilities:Provide...

  • Retail Sales Specialist

    4 weeks ago

    Portage, Michigan, United States Chowhound Full time

    At Chow Hound, our mission is straightforward - to provide the finest pet products available, assist pet owners with their inquiries, and contribute positively to the communities we support. As a sales associate, you will find fulfillment in aiding a pet owner in selecting the ideal food for their beloved companion, guiding a child in caring for their new...

  • Event Coordinator

    1 week ago

    Portage, Michigan, United States Michaels Stores Full time

    Event Coordinator - Part TimeMichaels Stores is seeking a highly organized and enthusiastic Event Coordinator to join our team. As an Event Coordinator, you will be responsible for planning, coordinating, and facilitating events within our stores to provide a stress-free, fun, and engaging experience for our guests.Key Responsibilities:Plan and coordinate...

Staff Specialist, Adverse Event Reporting Divisional Process Owner

4 months ago

Portage, United States Stryker Full time

Why RA/QA at Stryker?

Are you interested in working for a global company where you can work across functions and on a wide-variety of projects? As a member of Stryker's RA/QA team, that is exactly what you will do Here, we provide our RA/QA team the opportunity to learn new things, as well as endless growth opportunities If you are interested in working at one of the World’s Best Workplaces, apply now 

Need another reason to apply? Here are 10 reasons to join our Regulatory Affairs/Quality Assurance team: 

We are proud to be named one of the World’s Best Workplaces and a Best Workplace for Diversity by Fortune Magazine Learn more about our award-winning organization by visiting 

Stryker is hiring a Staff Specialist, Adverse Event Reporting Divisional Process Owner (Hybrid) to be the vanguard of excellence within our esteemed Instruments Division, who will be the guardian of regulatory adherence, you'll lead the charge in fortifying our adverse event reporting processes to meet and exceed the rigorous standards set by governing bodies. In this hybrid role, you'll be more than just a compliance champion – you'll be a catalyst for innovation and efficiency. With your finger firmly on the pulse of regulatory updates, you'll spearhead transformative changes, ensuring our reporting processes remain at the peak of effectiveness.

Who we want:

Meticulous documenters. Detail-oriented people who enjoy maintaining meticulous documentation of reports, metrics, proposals, and presentations.

Self-directed initiators. People who take ownership of their work and need no prompting to drive productivity, change, and outcomes.

Analytical problem solvers. People who go beyond, by identifying root causes, evaluating optimal solutions, and recommending comprehensive solutions to prevent future issues.

What you will do:

Ensure compliance with regulatory requirements for adverse event reporting (AER), including updates and changes.

Support audits related to AER, MDR, and MIR records.

Assist in quarterly VMSR submissions and NC/CAPA activities.

Participate in GPO calls and MIR Forum sub-team meetings.

Lead Monthly Late AER Board documentation and present metrics at QRB meetings.

Develop procedures for AER, provide training, and conduct risk assessments.

Act as primary liaison with regulatory agencies for AER.

Implement quality assurance measures for AER reports.

Continuously improve AER process and regulatory compliance.

Manage annual licenses, registrations, and listings.

Ensure regulatory compliance in advertising, post-market requirements, and product safety reporting.

Handle regulatory strategy, recalls, and communication with stakeholders.

Provide regulatory input throughout the product lifecycle.

Identify and address regulatory obstacles and market access requirements.

Evaluate products for regulatory classification and jurisdiction.

Determine submission requirements and compliance activities.

Provide regulatory guidance for product development.

Negotiate with regulatory authorities.

Develop and implement new regulatory procedures and SOPs.

Train stakeholders on regulatory requirements and assist in SOP development.

What you will need

Bachelor’s degree required, preferred in a Science or Engineering discipline.

Minimum of 5 years’ experience in post market surveillance and/or Adverse Event Reporting (AER).

Demonstrated adept project management skills, focusing on technical and scientific regulatory tasks.

Proficient in regulatory pathways, risk-benefit analysis, and effective communication both internally and externally.

Executes tasks from submission to post-marketing surveillance, ensuring compliance and documentation.

Works independently under general supervision, overseeing assignments, reviewing progress, and suggesting procedural changes.

Exercises autonomy in decision-making, while seeking diverse perspectives and embracing feedback for continuous improvement.

Capable of directing specialist teams and navigating organizational dynamics to achieve desired outcomes.

Proactively seeks challenging opportunities for personal and professional growth.

About Stryker

Our benefits:

12 paid holidays annually

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.

For a more detailed overview of our benefits or time off, please follow this link to learn more: US Stryker employee benefits

About Stryker
Stryker is a global leader in medical technologies and, together with its customers, is driven to make healthcare better. The company 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 130 million patients annually. More information is available at 

Know someone at Stryker?
Be sure to have them submit you as a referral prior to applying for this position. Learn more about our employee referral program on our referral page

Stryker is driven to work together with our customers to make healthcare better. Employees and new hires in sales and field roles that require access to customer accounts as a function of the job may be required, depending on customer requirements, to obtain various vaccinations as an essential function of their role.