-
Regulatory Affairs Specialist
4 weeks ago
Internetwork Expert Inc Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Regulatory Affairs Specialist
2 weeks ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essen ...
-
Sr Manager, Regulatory Affairs
8 hours ago
Thermo Fisher Scientific Carlsbad, United States Full timeAs part of the Thermo Fisher Scientific team, you'll discover meaningful work that makes a positive impact on a global scale. Join our colleagues in bringing our Mission to life every single day to enable our customers to make the world healthier, cleaner and safer. · Location/Di ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Alphatec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
1 day ago
Atec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions.Essential D ...
-
Sr. Specialist, Regulatory Affairs
2 weeks ago
Alphatec Spine Carlsbad, United StatesJob Description · Job DescriptionThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulator ...
-
Sr Regulatory Affairs Specialist
1 day ago
Actalent Carlsbad, United States: The Sr. Regulatory Affairs Specialist - Europe participates and manages necessary regulatory and project management activities required for medical device registration and compliance, with a focus on European Medical Device registration. The candidate must have successfully dem ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Atec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Regulatory Affairs Specialist
4 weeks ago
Alphatec Spine Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Regulatory Affairs Specialist
3 weeks ago
Internetwork Expert Inc Carlsbad, United StatesATEC Spine has an exciting opportunity for a Regulatory Affairs Specialist to work on-site at our location in San Diego, California. The Regulatory Affairs Specialist will support the development of submissions for domestic and international clearances for spine surgery products; ...
-
Regulatory Affairs Specialist
3 weeks ago
Alphatec Spine Carlsbad, United StatesPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essential Duties And Responsibilities ...
-
Regulatory Affairs Specialist
1 week ago
Alphatec Spine Carlsbad, United StatesPrimary responsibilities include the development of submissions for domestic and international clearances. Additionally, will assist to support daily activities such as new product development, change control, and post market surveillance. · Essential Duties And Responsibilities ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Alphatec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions. · Essentia ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Atec Spine Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Sr. Specialist, Regulatory Affairs
3 weeks ago
Atec Spine Carlsbad, United StatesThe Senior Regulatory Affairs Specialist will be responsible for the development of submissions for domestic and international clearances; as well as the support of daily activities related to new product development, change control, and regulatory product submissions. · Essenti ...
-
Sr. Specialist, Regulatory Affairs
4 weeks ago
Internetwork Expert Inc Carlsbad, United StatesThe Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, an ...
-
Manager, Medical Affairs, GIME Grants
2 weeks ago
Jazz Pharmaceuticals Carlsbad, United States Full timeBrief Description: · The Manager of Global Medical Affairs, Independent Medical Education (IME) Grants will be responsible for the successful development and management of the global medical education grant program for assigned therapeutic areas (Tas). The position will support ...
-
Senior Principal Statistician, Biostatistics
3 weeks ago
Jazz Pharmaceuticals Carlsbad, United States Full timeBrief Description: · The Senior Principal Statistician, Biostatistics will be a lead statistician on individual studies, across related studies, and for integrated summaries and will design and report Phase I to IV clinical studies and regulatory filings under the supervision of ...
-
Sr. Manager, Clinical Research
5 hours ago
Atec Spine Carlsbad, United StatesATEC Spine has an exciting opportunity for a Senior Manager of Clinical Research & Strategy as a member of the Scientific Affairs team located in Carlsbad, California. ATEC's Scientific Affairs team is responsible for regulatory, testing, and research activities supporting the co ...
-
Director of Clinical Research
4 weeks ago
Alphatec Spine Carlsbad, United StatesATEC Spine has an exciting opportunity for a Director of Clinical Research & Strategy as a member of the Scientific Affairs team located in Carlsbad, California. ATEC's Scientific Affairs team is responsible for regulatory, testing, and research activities in support of the compa ...
Sr. Specialist, Regulatory Affairs - Carlsbad, United States - Internetwork Expert Inc
Description
The Regulatory Affairs Senior Specialist will be responsible for providing regulatory support of spinal implant and instrument product launches for domestic and international countries; as well as the support of daily activities related to product design teams, design control, and regulatory product submissions.
Collaborates as a core team member on new product development teams of US Class II implants and Class I and Class II instruments.
Independently determines and documents appropriate regulatory strategy for proposed new products. Supports design control activities.Prepares and acts as lead correspondent of regulatory submissions, including 510(k) premarket notifications for US FDA.
Prepares regulatory submissions, including STEDs, EPCs, and DoCs, to support registration of products in Australia.
Responsible for internal process improvements, data/metric evaluation, maintenance of databases, and public-facing information.
Assists with post-market surveillance evaluation, trending, and reporting including updates to risk management (e.g., FMEA) process.
Reviews product labeling and promotional materials to ensure consistency with regulatory approvals.
Researches sources of regulatory information (e.g., regulatory agency websites, standards organization websites, literature, trade sheets, competitor information, etc.).
Provides department support during internal and external audits.
Assists in developing, maintaining, assigning, and tracking company Standard Operating Procedures (SOPs) to ensure compliance with applicable global regulatory requirements.
Maintains FDA establishment listings and registration.Demonstrates continuous pursuit of regulatory knowledge to obtain experience and expertise in product submissions and regulatory topics, including FDA regulations, 510(k)s, labeling and promotional materials, ISO 13485, ISO 14971, 21 CFR 820, global medical device registration, technical writing, and external standards.
Other duties as assignedThe requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Typically requires a bachelor's degree in
engineering or life sciences and five years of experience in the medical
device industry.
Strong knowledge of FDA Quality System
Requirements (QSR) and ISO 13485.
Orthopedic or spine experience strongly
preferred.
RAC certification preferred.
Must have 510(k) submission experience.
Must be detail oriented and possess strong
technical writing skills.
Must possess strong interpersonal
communication, teamwork and organizational skills.
Education and Experience
Minimum 4 Year / Bachelor's Degree
5+ Years of Relevant Experience
For roles based in the United States that require access to hospital facilities, must be eligible for and maintain credentials at all required hospitals, including meeting any applicable physical requirements or vaccination requirements (including the COVID-19 vaccine, as applicable).
ATEC is committed to providing equal employment opportunities to its employees and applicants without regard to race, color, religion, national origin, age, sex, sexual orientation, gender identity, gender expression, or any other protected status in accordance with all applicable federal, state or local laws.
Further, ATEC will make reasonable accommodations that are necessary to comply with disability discrimination laws.Salary Range
Alphatec Spine, Inc.
complies with state and federal wage and hour laws and compensation depends upon candidate's qualifications, education, skill set, years of experience, and internal equity.
$110,000 to $145,000 Full-Time Annual Salary#J-18808-Ljbffr