Stryker
Staff Regulatory Affairs Specialist, Pharmaceuticals (Remote)
Stryker, Lansing, Michigan, United States
Employer Industry: Pharmaceuticals
Why consider this job opportunity
Salary up to $207,400 plus bonus eligibility
Comprehensive benefits package
Opportunity for career advancement and growth within the organization
Work remotely anywhere within the continental U.S.
Chance to contribute to innovative medical products that improve patient outcomes
Supportive and dynamic work environment that encourages adaptability
What to Expect (Job Responsibilities)
Prepare complex submissions for pharmaceutical product approvals for clinical investigations and commercial distribution
Assess post‑approval changes to determine regulatory filing categories and ensure compliance
Advise personnel on regulatory pathway options and requirements
Develop and maintain positive relationships with regulatory agencies through effective communication
Contribute regulatory input throughout the product lifecycle to ensure compliance
What is Required (Qualifications)
Bachelor’s Degree
4+ years of experience in an FDA‑regulated industry
2+ years of pre‑ and/or post‑market Regulatory Affairs experience
Experience preparing submissions and/or supporting documents for clinical investigations and commercial distribution
Ability to comply with changing regulatory environments and prioritize work effectively
How to Stand Out (Preferred Qualifications)
Bachelor's Degree in Health Science or equivalent focus
4+ years of regulatory affairs experience within pharmaceuticals
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
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Why consider this job opportunity
Salary up to $207,400 plus bonus eligibility
Comprehensive benefits package
Opportunity for career advancement and growth within the organization
Work remotely anywhere within the continental U.S.
Chance to contribute to innovative medical products that improve patient outcomes
Supportive and dynamic work environment that encourages adaptability
What to Expect (Job Responsibilities)
Prepare complex submissions for pharmaceutical product approvals for clinical investigations and commercial distribution
Assess post‑approval changes to determine regulatory filing categories and ensure compliance
Advise personnel on regulatory pathway options and requirements
Develop and maintain positive relationships with regulatory agencies through effective communication
Contribute regulatory input throughout the product lifecycle to ensure compliance
What is Required (Qualifications)
Bachelor’s Degree
4+ years of experience in an FDA‑regulated industry
2+ years of pre‑ and/or post‑market Regulatory Affairs experience
Experience preparing submissions and/or supporting documents for clinical investigations and commercial distribution
Ability to comply with changing regulatory environments and prioritize work effectively
How to Stand Out (Preferred Qualifications)
Bachelor's Degree in Health Science or equivalent focus
4+ years of regulatory affairs experience within pharmaceuticals
RAC certification or Advanced Degree (Masters in Regulatory Affairs)
We prioritize candidate privacy and champion equal‑opportunity employment. Central to our mission is our partnership with companies that share this commitment. We aim to foster a fair, transparent, and secure hiring environment for all. If you encounter any employer not adhering to these principles, please bring it to our attention immediately.
We are not the EOR (Employer of Record) for this position. Our role in this specific opportunity is to connect outstanding candidates with a top-tier employer.
#J-18808-Ljbffr