Stryker is seeking a Principal Regulatory Affairs Specialist to support our Instruments division. This is a Hybrid or Remote role with in office expectations, to be based in Portage, Michigan. Candidates that reside within the Central US or are willing to relocate will be given preference.
This role is ideal for a regulatory expert with a strong track record in global submissions and cross-functional collaboration.
What you will do
Lead global regulatory strategies for new product development and market expansion
Prepare and manage submissions to FDA, Notified Bodies, and other global agencies
Advise cross-functional teams on regulatory pathways, risks, and compliance requirements
Provides in-depth understanding and ability to incorporate regulatory strategies to expedite development for products intended for serious or life-threatening medical conditions or that address unmet medical needs (e.g. orphan, conditional approval, breakthrough therapy)
Monitor and interpret evolving regulations to ensure ongoing product compliance
Critically assesses the impact of changing regulations on preapproval and post approval strategies and approaches based on changing regulations
Represent the company in high-level negotiations with regulatory bodies
Guide labeling, claims, and clinical strategies to align with regulatory expectations
Develop and implement regulatory SOPs and training programs
What you need
Required
Bachelor’s degree in Engineering, Science, or related field
9+ years experience in an FDA regulated industry
7+ years experience in medical device regulatory affairs
Proven experience with FDA submissions and global regulatory interactions
Deep knowledge of 21 CFR, MDD/MDR, and post-market requirements
Preferred
MS in Regulatory Science and/or RAC
Experience with Class I/II devices; PPE and M&A exposure
Strong understanding of eCTD and regulatory documentation systems
$115,600.00 - $245,800.00 USD Annual salary plus bonus eligible + benefits. Actual minimum and maximum may vary based on location. Individual pay is based on skills, experience, and other relevant factors.
...Entry-Level Amazon Freelance Writing Jobs Work from Home, No Degree Required Create and Publish Books on Amazon Without Writing Them Yourself This is not your average freelance writing gig. If you're tired of hustling for short-term projects, endlessly pitching...
...hiring a Full-time remote position for an Agent and Manager in IN, IL, KY, MI, OH AND WI.... ...High Personal Integrity and Character Work Ethic, Self Motivation and a Desire to Succeed... ...Ability to Consistently Work from Home with Success Benefits and Perks Large...
Virtual Assistant - Data Entry Clerk - Data Entry Operator - Administrative Assistant - Customer Service Representative - Call Center - Desktop Support Specialist - Email Chat Support (remote positions) Location: United States (Remote) LifeLearn empowers veterinary...
...online at Behavioral Health Connections (BHC) in Atlanta, GA is seeking a dynamic and talented Call Center Specialist Full Time Weekend Nights 8p-8:30am shift, to join the team of compassionate, dedicated professionals. The Call Center Specialist performs administrative...
Now Hiring! Metal Buildings Industry Detailer Custom designed workshops, garages, storage buildings, ag buildings; residential, commercial and industrial buildings. Our client offers products that can be found all around you! How can you help? By preparing...