Regulatory Affairs Sr Specialist
Remote · USFull-timeSeen todaySeen in employer's feed today
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At a glance
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Job overview
Zimmer Biomet seeks a Regulatory Affairs Sr Specialist to support regulatory submissions and product approvals. The role provides regulatory direction and strategy for development teams, evaluates regulatory risks, reviews labeling and promotional materials, and interprets FDA regulations for the organization. It permits full-time remote work throughout the U.S. and requires up to 15% domestic travel.
Skills & qualifications
Skills
Qualifications
Full job description
At Zimmer Biomet, we believe in pushing the boundaries of innovation and driving our mission forward. As a global medical technology leader for nearly 100 years, a patient’s mobility is enhanced by a Zimmer Biomet product or technology every 8 seconds.
As a Zimmer Biomet team member, you will share in our commitment to providing mobility and renewed life to people around the world. To support our talent team, we focus on development opportunities, robust employee resource groups (ERGs), a flexible working environment, location specific competitive total rewards, wellness incentives and a culture of recognition and performance awards. We are committed to creating an environment where every team member feels included, respected, empowered and recognised.
What You Can Expect
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Assist with the assembly, distribution, storage, tracking and retrieval of information pertinent to the regulatory process, including the regulatory submissions process; author and publish electronic submissions.
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Respond to requests from foreign governments and/or distributors to prepare and submit documentation for marketing approval as well as provide routine regulatory information to associates and affiliates.
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Assist with research, analysis, and communication of information pertaining to the appropriate regulatory pathway for new or modified products.
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Provide regulatory direction to development project teams as a core team member and develop regulatory strategy for new products.
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Evaluate risk of proposed regulatory strategies and offers solutions.
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Review proposed labeling for compliance with applicable US and international regulations.
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Write, manage, and approve the development of package inserts.
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Review, evaluate, and approve promotion and advertising material for compliance with applicable regulations.
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Review proposed product changes for impact on regulatory status of the product.
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Interpret and apply FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
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Communicate with regulatory and governmental agencies.
How You'll Create Impact
What Makes You Stand Out
Requires a Bachelor’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.
Must have 5 years of experience in job offered or related position.
Requires 1 year of experience with Orthopedic or medical device industry.
Requires 3 years of experience with the following:
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Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
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Working with medical product and anatomic knowledge.
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Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams
Your Background
Requires a Master’s degree in engineering management, engineering, life sciences, or related field, or foreign equivalent.
Must have 3 years of experience in job offered or related position.
Requires 1 year of experience with Orthopedic or medical device industry.
Requires 3 years of experience with the following:
-
Knowledge of FDA and EU regulations (including labeling regulations) and regulations outside of the US/EU.
-
Working with medical product and anatomic knowledge.
-
Interpreting and applying FDA regulations to business practices and provides regulatory input, advice, and guidance to the organization and design teams.
Role permits full-time remote work throughout the U.S.
Physical Requirements
Travel Expectations
- Role requires up to 15% domestic travel.
EOE/M/F/Vet/Disability
How this job compares
Set against the 1,021 open Regulatory Affairs jobs on Olive Jobs, counted November 7, 2026.
- Pay
- This postingNot listed
- US median$142–203K/yr679 salary ranges
- US median$25–40/hr44 hourly ranges
- Openings
- Olive Jobs lists 11 open Regulatory Affairs jobs in Florida and 1,021 across the US. 15% of them nationwide are listed as remote or flexible.
- Hiring the most across the US
- Parexel56 open
- Otsuka America Pharmaceutical Inc.43 open
- AbbVie39 open
- Experience
- This posting asks for at least 3 years of experience — less than three in four Regulatory Affairs postings that state a minimum ask for (median 7 years, across 889 postings).
- Education
- 631 of the 1,021 open Regulatory Affairs jobs (62%) ask for a bachelor's degree or higher.
Counted across the open, public US postings on Olive Jobs on November 7, 2026. Pay medians are the middle values of the low ends and of the high ends of postings that list both ends of a range in the same cadence (a yearly salary or an hourly rate); a range's midpoint is halfway between its ends. Pay and experience figures resting on fewer than 20 postings are left out.
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