IntePros · 9 hours ago
Regulatory Affairs Manager
Audubon, PA
Full-time
Onsite
Senior Level, Lead/Staff
8+ years expIntePros is currently looking for a Regulatory Affairs Manager to join one of their growing Medical Device clients. The role involves preparing, filing, and gaining approval of submissions to the U.S. FDA, while managing submissions and ensuring compliance with relevant regulations.
ConsultingInformation TechnologyStaffing Agency
Responsibilities
Guides the US Regulatory team in preparing and filing 510(k), IDE, PMA submissions, FDA reports, all international regulatory submissions and registrations, responds to questions, and achieves timely regulatory clearance/approval for marketing
Develops Regulatory team expertise in project management, writing, testing methods, and product knowledge, and maintains staffing needs to support all current and near term US filings
Creates optimized regulatory strategies for 510(k) submissions, protocol development and study design, IDE / PMA submissions, and reports, to ensure most efficient approval times and most favorable labeling in terms of indications and reimbursement
Works with Product Development, Clinical Affairs, Quality, Management and other areas of the organization to obtain relevant information and subsequent review of submission content as needed
Reviews and approves Document Change Orders for US Regulatory, including Regulatory Pathway Form (RPF) determinations for all new and revised products, under departmental guidelines
Reviews and files Note-to-File documentation with engineering rationales for qualifying changes to 510(k) cleared products or systems and line extensions
Assists in review of product labeling and marketing materials
Provides regulatory oversight of changes in manufacturing facilities, processes, and procedures for PMA products
Assists in development of relevant regulatory SOPs and training staff as necessary
Ensures conformance to 21 CFR regulations
Assists with other regulatory matters as requested
Attends FDA meetings as requested
Understands relevant surgical techniques and clinical use of implant/instrument systems
Adheres to the letter and spirit of the company Code of Conduct, the AdvaMed Code, MedTech Code, and all other company policies
Ensures Compliance with applicable governmental laws, rules, and regulations, both in the United States and internationally, by completing introductory and annual training and maintaining knowledge of compliance as it applies to your role
Represents the company in a professional manner and uphold the highest standards of ethical business practices and socially responsible conduct in all interactions with other employees, customers, suppliers, and other third parties
Reasonable accommodations may be made to enable individuals with disabilities to perform these essential functions
Qualification
Required
Master's degree in engineering or science-related field, or equivalent
Minimum of 8 years' experience in the medical device industry, or equivalent
Minimum of 3 years' experience in a regulatory capacity within the medical device industry, or equivalent, preferably with orthopaedic or spinal devices
Demonstrated experience in obtaining 510(k) clearance
Demonstrated experience with IDE and PMA approval, preferably including panel-track PMA
Excellent verbal, written and organizational skills
Good computer skills
Must be detail-oriented
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
Company data provided by crunchbase