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Manager, Regulatory Affairs

1 week ago

Miami, Florida, United States InspireMD Full time
Job Description Job Description

Job Title: Sr. Manager/Manager, Regulatory Affairs Location: REMOTE US Department: Regulatory Affairs Reports To: Head of RA/QA, US Company: InspireMD (Class III PMA Medical Device)

About Us:

InspireMD is a dynamic growing company focused on developing and commercializing innovative Class III PMA and Class II medical devices. As we expand, we are seeking a highly motivated Manager, Regulatory Affairs to join our team. In this role, you will be pivotal in managing both premarket and postmarket regulatory activities, ensuring compliance with FDA regulations, and overseeing regulatory submissions. You will have the opportunity to contribute significantly to the company's growth, working with cross-functional teams to ensure regulatory success and maintain market access for our life-saving products.

Job Summary:

The Manager, Regulatory Affairs will be responsible for managing regulatory affairs activities across the product lifecycle, with a strong focus on both premarket and postmarket regulatory compliance for Class III PMA and Class II devices. You will be involved in regulatory submissions, FDA site registration and product listing, complaint handling, and maintaining product approvals. This is a leadership role within a fast-paced startup where you will work closely with the R&D, quality assurance, and operations teams to ensure compliance with applicable FDA regulations and maintain successful product registration and market access.

Key Responsibilities:

· Premarket Submissions: Manage and prepare regulatory submissions for new product approvals, including PMA, PMA-S, 510(k) submissions, IDE applications, and premarket notifications. Ensure compliance with FDA regulations and standards for Class III devices.

· Postmarket Compliance: Manage postmarket regulatory activities, including maintaining product approvals, managing product changes, and ensuring compliance with FDA regulations. Coordinate and execute any necessary postmarket submissions.

· Complaint Handling: Lead the complaint handling process, ensuring that all complaints are assessed, investigated, and documented in compliance with FDA requirements. Oversee the CAPA (Corrective and Preventive Action) process in collaboration with QA, ensuring appropriate actions are taken in response to complaints.

· FDA Site Registration and Product Listing: Manage FDA site registration and product listing for the company's medical devices. Ensure timely renewal and accurate maintenance of all registrations and listings in compliance with FDA requirements.

· Regulatory Strategy and Planning: Support the implementation of regulatory strategies for the US market, collaborating with the R&D and quality teams to ensure smooth regulatory pathways for new products and product modifications.

· Cross-functional Collaboration: Work closely with R&D, quality assurance, and operations teams to ensure alignment with regulatory requirements throughout the

product lifecycle. Provide regulatory guidance on labeling, promotional materials, and product changes.

· Regulatory Intelligence and Guidance: Stay up-to-date on changes to FDA regulations and industry standards. Advise internal teams on regulatory requirements, risks, and opportunities related to product development and market access.

· Inspection Support: Support FDA inspections and audits, ensuring that all regulatory and complaint handling documentation is in order and facilitating smooth interactions with regulatory authorities.

Qualifications:

· Education:

o Bachelor's degree in Life Sciences, Engineering, or a related field (required).

o Advanced degree (Master's or MBA) or Regulatory Affairs Certification (RAC) is a plus.

· Experience:

o 7+ years of experience in Regulatory Affairs within the medical device industry, with a strong focus on Class III PMA devices.

o Experience in both premarket and postmarket regulatory affairs, including preparing and submitting PMA, 510(k), IDE, and other FDA submissions.

o Strong background in complaint handling and CAPA processes, with experience managing regulatory compliance related to product complaints and adverse event reporting.

o Experience with FDA site registration and product listing processes for medical devices.

o Knowledge of FDA regulations (21 CFR 820, 21 CFR 807, 21 CFR 803, etc.) and international regulatory requirements (e.g., ISO 13485, MDR) is preferred.

o Experience working in a startup or fast-paced environment, with the ability to manage multiple projects and competing priorities.

· Skills:

o Strong analytical and problem-solving skills, with the ability to interpret and apply regulatory guidelines.

o Excellent organizational skills, with the ability to manage regulatory submissions, complaints, and product lifecycle requirements efficiently.

o Excellent verbal and written communication skills, with the ability to effectively communicate complex regulatory concepts to cross-functional teams.

o Ability to work independently and collaboratively in a team-oriented, fast-paced environment.

o Attention to detail and a proactive approach to compliance and regulatory challenges.