Top 12 Regulatory affairs Jobs in Kalamazoo Mi

Principal Regulatory Affairs Specialist, (Hybrid)
Stryker —Portage, MI
- $126,500 - $210,700 a year
- Full-time
- Hybrid work
- Engineering
- Research
- Master's degree
- Health savings account
- AD&D insurance
2d
Professional Regulatory Affairs - Lifecycle Management - Non-Medicines
Perrigo —Allegan, MI
- Hybrid work
- English
- Mid-level
- Office
Lead Professional Affairs Specialist
CONMED —Kalamazoo, MI
- $78,200 - $121,200 a year
- Full-time
- Microsoft Excel
- Microsoft Outlook
- 5 years
- Employee stock purchase plan
- Disability insurance
Quick Apply
2d
Senior Professional Regulatory Affairs - Lifecycle Management - Medicines
Perrigo —Allegan, MI
- Hybrid work
- 5 years
- English
- Office
Senior Professional Regulatory Affairs - Lifecycle Management - - Medicines
Perrigo —Allegan, MI
- Hybrid work
- 5 years
- Mentoring
- Senior level
Senior Compliance Engineer – Digital Health
Stryker —Portage, MI
- $77,700 - $129,500 a year
- Full-time
- Computer science
- Computer Science
- Office
- Health savings account
- AD&D insurance
11d
Pharmacy Technician - Full Time 72/pp
Bronson Healthcare —Battle Creek, MI
- Full-time
- Ability to walk for extended periods
- Inpatient
- Outpatient experience
Pharmacy Technician - Hospital Infusion Center
Bronson Healthcare —Battle Creek, MI
- Full-time
- Hospital
- Ability to walk for extended periods
- Inpatient
Pharmacy Technician - Part Time 48Hrs/Pp, Benefit Eligible - Bronson Battle Creek Outpatient
Bronson Healthcare —Battle Creek, MI
- Part-time
- Hospital
- Ability to walk for extended periods
- Outpatient experience
Lead Pharmacist
FAMILY HEALTH CARE CENTER OF KALAMAZOO —Kalamazoo, MI
- Full-time
- Spanish
- Microsoft Outlook
- Computer literacy
Quick Apply
14d

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Packaging Compliance Manager/Packaging Engineer in Regulatory Affairs - Columbus OH/Abbott Park, IL (internal OUS can apply)
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Evaluate various technical alternatives and perform risk assessment and analysis. Bachelor's degree (or equivalent) is required - preferred area of focus in…
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regulatory affairs jobs near kalamazoo mi

Principal Regulatory Affairs Specialist, (Hybrid)

Stryker -
Portage, MI

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Job Details

Full-time
$126,500 - $210,700 a year
2 days ago

Benefits

Health savings account
AD&D insurance
Employee stock purchase plan
Paid holidays
Disability insurance
Health insurance
Dental insurance
401(k)
Flexible spending account
Vision insurance
Prescription drug insurance

Qualifications

Research
Biomedical regulatory compliance
FDA regulations

Full Job Description

Why join Stryker?

Looking for a place that values your unique talents? Discover Stryker's award-winning culture.
We are proud to offer you our total rewards package which includes bonuses, healthcare, insurance benefits, retirement programs, wellness programs, as well as service and performance awards – not to mention various social and recreational activities, all of which are location specific.

Job description

We are excited to be named one of the World’s Best Workplaces by Fortune Magazine! We are proud to offer you 12 paid holidays annually. For an overview of our benefits and time off, please follow this link to learn more:US Stryker employee benefits.

Join Stryker's Instruments Division as a Principal Regulatory Affairs Specialist, where you will serve as a key regulatory expert supporting strategic business development and regulatory activities across the product lifecycle. In this highly visible role, you will partner closely with Business Development, Quality, Clinical, and Regulatory leaders to evaluate regulatory and quality risks, support due diligence activities related to acquisitions and partnerships, and help drive informed business decisions. This role offers unique exposure to strategic initiatives, executive stakeholders, and cross-functional collaboration while leveraging your deep regulatory expertise.

This unique position offers exposure across multiple functions, providing a career development opportunity beyond a traditional Regulatory Affairs role.

Work Flexibly: This is a hybrid role requiring a commutable distance to Portage, MI.

What You Will Do:

Partner with Business Development teams to support regulatory and quality due diligence activities for potential acquisitions.
Conduct research and analysis of new technologies, business models, product portfolios, and regulatory landscapes to support strategic decision-making.
Lead regulatory strategy development and execution for product development, commercialization, and lifecycle management activities.
Collaborate with cross-functional partners to support integration planning and ensure key regulatory and quality considerations are appropriately addressed following acquisitions.
Serve as a regulatory subject matter expert on significant projects, providing guidance on applicable regulations, standards, and compliance requirements.
Monitor global regulatory changes and communicate impacts, risks, and required actions to project teams and stakeholders.
Evaluate regulatory risks and develop mitigation strategies to support business and regulatory objectives.
Review project progress, assess regulatory deliverables, and recommend procedural improvements to enhance compliance and efficiency.
Collaborate with cross-functional teams to translate complex regulatory requirements into actionable project plans and compliance activities.

What You Will Need:

Required Qualifications

Bachelor's degree required. Degree in Engineering, Biological Sciences or equivalent focus preferred.

Minimum 8 years of relevant Regulatory Affairs/ Quality Assurance experience within an FDA-regulated industry.
Applied knowledge of FDA regulations and regulatory compliance requirements.

Preferred Qualifications

Regulatory Affairs Certification (RAC).
Master's degree in Regulatory Affairs or related discipline.
Medical device industry experience is strongly preferred.
Experience supporting products throughout the full product lifecycle, including product development, commercialization, post-market activities, and lifecycle management.
Experience supporting business development, due diligence, mergers and acquisitions (M&A), licensing activities, or other strategic business initiatives preferred.
Demonstrated ability to assess regulatory and quality risks, navigate ambiguity, and influence stakeholders across complex organizations.

USN: $126,500 - $210,700 USD Annual

View the U.S. work location and transparency guide to find the pay range for your location.

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.

Apply Now

Refine Your Search

regulatory affairs jobs in kalamazoo mi

Principal Regulatory Affairs Specialist, (Hybrid)

Professional Regulatory Affairs - Lifecycle Management - Non-Medicines

Lead Professional Affairs Specialist

Senior Professional Regulatory Affairs - Lifecycle Management - Medicines

Senior Professional Regulatory Affairs - Lifecycle Management - - Medicines

Senior Compliance Engineer – Digital Health

Pharmacy Technician - Full Time 72/pp

Pharmacy Technician - Hospital Infusion Center

Pharmacy Technician - Part Time 48Hrs/Pp, Benefit Eligible - Bronson Battle Creek Outpatient

Lead Pharmacist

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