Regulatory Affairs Specialist
GE HealthcareSalary not specified
Full Time
Junior (1 to 2 years)
Not SpecifiedCompensation
Mid-level (3 to 4 years), Senior (5 to 8 years)Experience Level
Full TimeJob Type
UnknownVisa
Medical Devices, HealthcareIndustries
Requirements
- Bachelor’s degree (B.S. or B.A.) required, preferably in Engineering, Science, or related field
- 4+ years of experience in a regulated industry required, preferably with medical devices
- Previous experience in Pre- or Post-Market Regulatory, Clinical, Quality, or Engineering
- Preferred: RAC certification or advanced degree (e.g., Master’s in Regulatory Affairs)
- Preferred: General understanding of FDA, EU, and international medical device regulations
- Willingness to travel 10%
Responsibilities
- Evaluate device modifications and implement actions to maintain global product compliance
- Analyze emerging regulatory intelligence and advise on potential impact to market access
- Provide regulatory input and technical guidance to product development teams for global requirements
- Determine requirements and options for regulatory submissions, approval pathways, and compliance activities
- Prepare and submit regulatory submissions in alignment with global regulations and guidelines
- Participate in audits to enable or maintain market access across international markets
- Identify gaps and contribute to development and implementation of new regulatory procedures and SOPs
- Support wireless technology compliance within medical devices to meet global regulatory standards
Skills
Key technologies and capabilities for this role
Questions & Answers
Common questions about this position
What is the work arrangement for this position?
The role offers hybrid work flexibility and is based in Portage, MI.
What are the minimum education and experience requirements?
A Bachelor’s degree (B.S. or B.A.), preferably in Engineering, Science, or related field, is required along with 4+ years of experience in a regulated industry, preferably medical devices, and previous experience in Pre- or Post-Market Regulatory, Clinical, Quality, or Engineering.
What is the salary range for this role?
This information is not specified in the job description.
How much travel is required in this position?
The role requires up to 10% travel.
What preferred qualifications will strengthen my application?
RAC certification, an advanced degree like a Master’s in Regulatory Affairs, and a general understanding of FDA, EU, and international medical device regulations are preferred.
Stryker
Develops and manufactures medical devices and equipment
About Stryker
Stryker develops and manufactures medical devices and equipment aimed at improving patient care and surgical efficiency. Their products include surgical tools, neurotechnology devices, and orthopedic implants, which are sold directly to hospitals and clinics. Stryker stands out from competitors by focusing on high-quality products and a commitment to advancing healthcare solutions. The company's goal is to enhance the overall healthcare experience for both patients and medical professionals.
Kalamazoo, MichiganHeadquarters
1941Year Founded
$423.3MTotal Funding
IPOCompany Stage
Biotechnology, HealthcareIndustries
10,001+Employees
Benefits
Medical & prescription plans
Supplemental health benefits
Flexible Spending accounts
Employee Assistance Program
Short-term & long-term disability
Tuition reimbursement
401(k) plan
Employee Stock Purchase Plan
Risks
Integration challenges from acquisitions may strain Stryker's resources.
Rapid tech advancements risk obsolescence of Stryker's current products.
Regulatory scrutiny on acquisitions could delay Stryker's market entry.
Differentiation
Stryker's acquisitions enhance its minimally invasive surgical solutions portfolio.
Entry into the peripheral vascular segment diversifies Stryker's market presence.
Stryker's focus on AI integration boosts diagnostic accuracy and operational efficiency.
Upsides
Growing demand for minimally invasive solutions aligns with Stryker's strategic acquisitions.
The orthopedic implants market growth benefits Stryker's expanding product line.
Stryker's acquisition of Inari Medical positions it in a high-growth vascular market.
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