Regulatory Affairs Specialist II
Vandergrift, PAFull-timeSeen 1 day agoSeen in employer's feed today
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Credentials this posting asks for.
Job overview
The Regulatory Affairs Specialist II plans and prepares submissions to obtain regulatory approvals for new and modified medical devices in specific markets. The role develops regulatory strategies, obtains and maintains approvals, and serves as a liaison between Cook manufacturers and local offices, distributors, and notified bodies. It also supports product changes, registration maintenance, and post-market regulatory activities.
Skills & qualifications
Skills
Qualifications
Full job description
Overview
The Regulatory Affairs Specialist II is responsible for the planning and preparation of submissions to obtain regulatory approvals for new and modified medical devices in specific markets. The Regulatory Affairs Specialist II develops regulatory strategies, obtains and maintains approvals, and serves as a communication liaison between the Cook manufacturer and the Cook International Local Office / Cook Distributor.
Responsibilities
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Maintain an excellent understanding of global medical device regulations regarding the following: ISO 13485, MDR 2017/745, FDA 21 CFR Part 820 and others as required.• Serve as a liaison on regulatory issues between the Cook manufacturer and Cook Local Office and/or Cook Distributor and Notified Body.• Prepare regulatory submissions for new products, product changes, and re-registrations as required for the specific regions.• Create, organize, and maintain technical documentation.• Maintain registration information (license numbers, expiration dates, etc.) and obtain re-registration approvals in advance of license expirations to ensure no disruption in product availability.• Provide support to currently marketed products as necessary including input on/ creation of change requests, etc.• Support post market regulatory activities such as Post Market Surveillance Plans, Post Market Clinical Follow Up (PMCF) Plans and Reports, and Periodic Safety Update Reports (PSURs).
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Maintain and organize appropriate regulatory records to demonstrate compliance with applicable regulations.• Ability to multi-task and work within defined deadlines.• Ability to interpret regulations and apply them to real-world scenarios.• Must work and interact effectively and professionally with and for others throughout various levels of the global organization.• Detail-oriented with strong organizational and project management skills.• Maintain regular and punctual attendance.• Must maintain company quality and quantity standards.• Must have effective oral and written communication skills.• Excellent problem solving skills and ability to work in collaborative and independent work situations and environments with minimal supervision.• Ability to remain calm and receptive in fast paced situations.
Qualifications
- Proficient in reading, writing and speaking English language.• Bachelor’s degree in relevant technical or scientific discipline.• Knowledge of medical device quality standards and regulatory requirements.• 3 years of experience in the medical device industry.• Computer experience required with working knowledge of Microsoft
Physical Requirements:
- General office environment• Sits for extended periods• Requires close visual acuity when working with computers, etc.• Requires occasional early morning or late evening teleconferences• International and domestic travel as required
Requisition ID2026-20290
Posting Date1 day ago(11/2/2026 1:31 PM)
Job Location(s)Vandergrift PA United States
Job LocationsUS-PA-Vandergrift
TravelLess than 10%
Position TypeFull Time
CompanyCook Vandergrift
CategoryRegulatory Affairs
How this job compares
Set against the 996 open Regulatory Affairs jobs on Olive Jobs, counted November 4, 2026.
- Pay
- This postingNot listed
- Pennsylvania median$126–201K/yr25 salary ranges
- US median$26–40/hr39 hourly ranges
- Openings
- Olive Jobs lists 52 open Regulatory Affairs jobs in Pennsylvania and 996 across the US. 15% of them nationwide are listed as remote or flexible.
- Hiring the most in Pennsylvania
- GlaxoSmithKline LLC6 open
- Teva Pharmaceuticals5 open
- Globus Medical, Inc.4 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 864 postings).
- Education
- This posting asks for a bachelor's degree; 621 of the 996 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 4, 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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