IntePros · 5 days ago
Regulatory Affairs Specialist
Audubon, PA
Full-time
Onsite
Mid, Senior Level
2+ years expIntePros is currently looking for a Regulatory Affairs Specialist to join one of their growing Medical Device clients in Audubon, PA. The Regulatory Affairs Specialist drafts, submits and gains clearance for 510(k) submissions, and approval for IDE/PMA submissions to the FDA for class II and class III products.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Partners with Product Development and management to prepare and review 510(k) submissions
Prepares final 510(k) submissions and obtaining required management approvals
Submits 510(k) documents and responding to the FDA in a timely manner
Assists in the completion of IDE and PMA submissions for IDE clinical trials
Helps to prepare PMA packages, including non-clinical, manufacturing, and clinical sections
Works with personnel in various functional areas to obtain timely submissions to FDA
Obtains and reviews clinical study data with Clinical Data Manager and other Clinical Affairs personnel, as needed for IDE and PMA reporting
Reviews Document Change Orders for Regulatory compliance, including drawings and labeling changes
Performs routine maintenance of approved PMAs, including coordination and preparation of PMA supplements, Annual Reports
Trains new staff on relevant Regulatory processes as necessary
Determines Regulatory Pathway for new/changed products under departmental guidelines
Reviews and approve Regulatory Pathway Forms and supporting documentation
Reviews and approves Note-to-File documentation for minor changes to 510(k) cleared products or systems
Understands the company’s products, surgical techniques and the use of implant and instrument systems
Develops relevant Regulatory SOPs as necessary
Qualification
Required
Bachelor's degree in health or science-related field, or equivalent; Engineering degree is a plus
Minimum of 2-5 years' experience in Regulatory Affairs in the medical device industry, preferably within orthopedic medical devices
Experience in medical device development and registration of products
Demonstrated knowledge of US regulatory submissions; Pre-Sub, and 510(k); working knowledge of IDE and PMA submissions a plus
Experience assessing regulatory impact of product/process changes
Experience reviewing labeling, promotional literature, etc
Excellent communication and listening skills
Proficient with Microsoft Office, including Word, Excel, PowerPoint and Teams
Strong time management skills, demonstrated ability to work on multiple projects, priorities simultaneously
Able to work independently as well as within a team
Company
IntePros
IntePros is an established, woman-owned, privately-held technology and business services consulting agency committed to building long-term relationships and helping more companies leverage the power of a more diverse workforce.
201-500 employees
H1B Sponsorship
IntePros has a track record of offering H1B sponsorships. Please note that this does not
guarantee sponsorship for this specific role. Below presents additional info for your
reference. (Data Powered by US Department of Labor)
Distribution of Different Job Fields Receiving Sponsorship
Represents job field similar to this job
Trends of Total Sponsorships
2025 (3)
2024 (3)
2023 (6)
2022 (7)
2021 (6)
2020 (13)
Funding
Current Stage
Growth StageLeadership Team
Loren Kovalcik
CEO
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