Senior Regulatory Affairs Specialist

Develop regulatory submissions for domestic and international spinal product clearances. Support our spinal product design teams concerning change control and spinal product regulatory submissions. Duties include:

1. Provide expertise on domestic and OUS regulatory strategies for products, including spinal devices, medical software (SaMD), medical devices containing software, radiation emitting devices, and cybersecurity;
2. Support design control activities for spinal devices, medical software (SaMD), medical devices containing software, and radiation emitting devices;
3. Apply IEC 62304 requirements during the development and improvement of the software lifecycle process for domestic and OUS submissions;
4. Prepare regulatory submissions, including 510(k) premarket notifications for the FDA;
5. Maintain FDA establishment listings and registration;
6. Prepare regulatory submissions, including technical files and design dossiers for the registration of spinal products in the European Union, Australia, and New Zealand; interface with Notified Bodies regarding significant changes to our spinal products;
7. Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information for regulatory submissions concerning our spinal products;
8. Assist with post-market surveillance evaluation, trending, and reporting concerning our spinal products, including updates to our risk management (e.g., FMEA) process;
9. Review spinal products’ labeling and promotional materials to ensure consistency with regulatory approvals;
10. Conduct research on sources of regulatory information (e.g., regulatory agency websites, standards organizations’ websites, literature, trade sheets, competitor information, etc.);
11. Provide department support during internal and external regulatory audits; and
12. Develop, maintain, assign, and track company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.

May telecommute part of the week from commuting distance to Carlsbad, CA in accordance with the company’s flexible working policy.

Requirements

A Master’s degree or foreign equivalent in Regulatory Affairs, Biomedical Engineering, Biology, or a closely related field plus 2 years of post-baccalaureate experience in a regulatory affairs specialist-related occupation.

In the alternative, the employer will accept a Bachelor’s degree or foreign equivalent in Regulatory Affairs, Biomedical Engineering, Biology, or a closely related field followed by 5 years of post-baccalaureate experience in a regulatory affairs specialist-related occupation.

Experience must include the following, which may have been gained concurrently:

1)    2 years of 510(k) submission experience;

2)    2 years of experience with FDA Quality System Requirements (QSR) and ISO 13485;

3)    2 years of experience with MDD 93/42/EEC, MDR 2017/745, and New Zealand quality system requirements;

4)    2 years of experience with orthopedic or spinal devices and their clinical usefulness;

5)    2 years of experience with medical devices containing software and software as a medical device (SaMD);

6)    2 years of experience determining the appropriate regulatory strategy for spinal- or software-based medical devices;

7)    2 years of experience liaising with regulatory agencies and supporting site audits for medical device products;

8)    1 year of experience reviewing labeling and promotional materials;

9)    1 year of experience with process improvement activities under company’s QMS;

10)  1 year of experience creating and maintaining FDA establishment registration and device listings.

Job site: 1950 Camino Vida Roble, Carlsbad, CA 92008. Full-time. Salary: $137,500 to $145,000.

To learn more & to apply online, visit our website at: https://atecspine.com/careers/ & reference Req: Senior Regulatory Affairs Specialist.