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Regulatory Compliance Specialist
2 months ago
Our client, a prominent manufacturer and distributor in the medical device sector, specializes in anesthesia and respiratory solutions. They are recognized for their commitment to innovation, consistently acquiring, licensing, and launching new products globally. With a presence in over 105 countries and operations across 12 nations, they also manage in-house manufacturing overseas.
The Regulatory Affairs Specialist will play a pivotal role in supporting the global regulatory functions of the organization, particularly focusing on the United States market. This position is essential for securing and maintaining all necessary federal and state regulatory approvals for the company's products. The role involves providing strategic direction, ensuring alignment with corporate processes, and guaranteeing compliance with all relevant U.S. federal and state regulations.
This is an exceptional chance to join a company that values outstanding leadership and is dedicated to high standards of quality, service, and customer value. The organization is experiencing rapid growth, making it an exciting time to become part of their future.
Key Responsibilities:
- Develop and lead regulatory strategies and submissions to the FDA and state authorities for new product approvals, along with supporting existing products.
- Offer regulatory guidance to product development teams to ensure that documentation meets regulatory submission requirements.
- Review technical documentation, such as test reports and protocols, for completeness and adherence to regulatory standards, using scientific judgment to identify and address any gaps.
- Prepare materials for license renewals, updates, and registrations in a timely manner.
- Evaluate company marketing materials for compliance with applicable regulations.
- Maintain an up-to-date understanding of current Quality System Regulations (QSR) and ISO standards.
- Support Quality Management Functions as necessary.
- Bachelor's Degree in a Science or Engineering discipline or equivalent business experience.
- A minimum of 3 years of experience in the regulatory affairs department of a medical device organization.
- Familiarity with global Class I, II, and/or III medical device regulations is preferred.
- Proven project management skills to effectively plan and execute system assessments.
- Experience in communicating with state and federal regulatory agencies is essential.
- Prior experience with FDA and Notified Body inspections is highly desirable.
- Professional certifications (e.g., RAPS, CQA, CQM, and/or CQE) are advantageous but not mandatory.
- Experience with 510(k) submissions is beneficial but not required.
- Ability to interpret domestic and international regulations relevant to company operations.
- Must be legally authorized to work in the United States.
- Preferred qualifications include being licensed in California as a Designated Representative in Charge for Wholesaler (DRIC); qualifications to obtain DRIC license are required.
