Senior Regulatory Affairs Specialist

Our client is a leading medical devices company dedicated to improving patient outcomes through innovative and high-quality medical technologies. They specialize in the development, manufacturing, and distribution of advanced medical devices that adhere to strict regulatory requirements. As a Senior Regulatory Affairs Specialist, you will play a crucial role in ensuring their products meet regulatory compliance standards, allowing us to deliver safe and effective solutions to healthcare professionals and patients.

They are seeking an experienced and detail-oriented Senior Regulatory Affairs Specialist to join their dynamic regulatory affairs team. In this role, you will be responsible for developing and implementing regulatory strategies to gain and maintain regulatory approvals for their medical devices. You will collaborate with cross-functional teams, including product development, quality assurance, and clinical affairs, to ensure compliance with relevant regulations and standards. The ideal candidate will have a strong understanding of the regulatory landscape in the medical devices industry, excellent analytical skills, and the ability to communicate effectively with internal and external stakeholders.

Responsibilities:

1. Develop and execute regulatory strategies to support product development, registration, and approval processes for medical devices.
2. Ensure compliance with applicable global regulations, standards, and guidelines (e.g., FDA, ISO, MDR, etc.).
3. Prepare and submit regulatory submissions, including 510(k) pre-market notifications, CE Marking applications, and other relevant documentation.
4. Conduct regulatory reviews of product labeling, advertising, and promotional materials to ensure compliance with regulatory requirements.
5. Collaborate with cross-functional teams to provide regulatory guidance and support throughout the product lifecycle, including design control, risk management, and clinical evaluation processes.
6. Stay up to date with changes in regulatory requirements and communicate the impact on the organization's products and processes.
7. Participate in regulatory agency inspections and audits, as necessary, and assist in resolving any findings or observations.
8. Support post-market surveillance activities, including complaint handling, adverse event reporting, and product recalls, as required.
9. Interact with regulatory agencies, notified bodies, and other external stakeholders to facilitate product registrations, submissions, and approvals.
10. Provide training and guidance to junior regulatory affairs team members.

Qualifications:

1. Bachelor's degree in a scientific or related field. Advanced degree is a plus.
2. Minimum of 5 years of experience in regulatory affairs within the medical devices industry, with a focus on Class II and/or Class III devices.
3. Strong knowledge of US FDA regulations (e.g., 21 CFR 820, 21 CFR 803, 21 CFR 806) and international regulatory requirements (e.g., ISO 13485, MDR, etc.).
4. Experience in preparing and submitting regulatory submissions, including 510(k) pre-market notifications and CE Marking applications.
5. Familiarity with risk management processes and design control requirements.
6. Excellent written and verbal communication skills, with the ability to effectively communicate complex regulatory information to both technical and non-technical stakeholders.
7. Detail-oriented mindset with exceptional organizational and analytical skills.
8. Ability to work independently, prioritize tasks, and meet deadlines in a fast-paced and dynamic environment.
9. Proficiency in using regulatory affairs software and document management systems.
10. Regulatory affairs certifications (e.g., RAC) are desirable but not required.

Join their passionate team of professionals committed to making a positive impact in the medical devices industry. Apply today and contribute to the development of life-saving technologies!

Please note that the above job description is intended to provide an overview of the role and responsibilities of a Senior Regulatory Affairs Specialist. The specific duties and requirements may vary based on the company's needs and industry regulations.