Position Overview:
Collaborate with a cross-functional team to provide comprehensive regulatory support for both new product launches and existing product lines. Engage with quality teams, engineers, and technical experts to address and resolve regulatory issues and inquiries from regulatory agencies.
Key Responsibilities:
- Offer regulatory guidance and input to cross-functional teams, developing and implementing global regulatory strategies for various devices. Prepare and submit regulatory submissions for both U.S. and international markets.
- Prepare and manage Technical Files, Design Dossiers, Change Notifications, and Submissions (including Documentary Audits under MDD/MDR) for regulatory agencies and distributors.
- Create, review, and approve change requests to ensure compliance with regulatory requirements.
- Assist in defining regulatory strategies and manage submission activities for complex product development projects and the maintenance of approved products.
- Interpret and apply new or existing regulatory requirements to the product portfolio and regulatory and quality system procedures.
- Support or prepare regulatory submissions for new products and product changes, ensuring timely market release approvals. Review significant product submissions with management and negotiate submission issues with regulatory agencies.
- Review protocols and reports to support regulatory submissions.
- Maintain up-to-date knowledge of global quality and regulatory requirements.
- Demonstrate strong project management skills, particularly in the writing, coordination, and execution of regulatory tasks, with an emphasis on technical and scientific activities.
- Provide regulatory input for product lifecycle planning and ongoing support to product development teams.
- Support clinical studies by preparing and submitting regulatory documents, facilitating site interactions, addressing site requests, and maintaining study documentation.
Minimum Requirements:
- B.S. degree in Biomedical Engineering, Biotechnology, Regulatory Sciences, or a related field. Certifications with RAPS, ASQ, or CQE are preferred.
- 3-5 years of experience in International Regulatory Affairs, preferably within the Medical Device industry.
- Experience with Class II medical devices, including implants.
- Familiarity with 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC), and European Medical Device Regulation 2017/745.
- Working knowledge of ISO 13485 and ISO 14971 standards.
Desired Qualifications:
- Experience with clinical studies and medical device software requirements and regulations.
- Ability to work effectively within project teams and manage multiple priorities with minimal oversight.
- Strong analytical and problem-solving skills, with the ability to identify risks and escalate issues as needed.
- Prior involvement with product development teams and a solid understanding of the product development process and design control.
- Proficiency in writing clear, understandable technical documents, including regulatory documentation and scientific presentations.
- Experience in data analysis and providing informed recommendations based on assembled facts.
- Strong organizational skills, attention to detail, and a process-oriented approach.
- Effective interpersonal and communication skills.
- Experience supporting products from concept through end-of-life phases.
- Proficiency in MS Office Suite (Word, Excel, PowerPoint, and Adobe).
- Regulatory Affairs Certification (RAC) is a plus.
