Sr. Regulatory Affairs Specialist

Caldera Medical•Westlake Village, CA

5d•Onsite

About The Position

In your role as a Sr. Regulatory specialist, you will develop and implement medical device regulatory strategies to obtain timely approvals from worldwide regulatory bodies. From developing and authoring regulatory submissions to providing critical input on cross-functional project teams you will ensure submissions are accurately prepared and comply with global regulations. The position is on-site at our Westlake Village location and may require additional hours and/or travel as necessary to complete time-sensitive projects.

Requirements

Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering, or a related field.
5-7 years of regulatory affairs experience in the medical device industry.
Strong understanding of EU MDR 2017/745, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other international medical device regulations.
Proven experience in preparing regulatory submissions such as Technical Files, STED (Summary Technical Documentation), CE Marking dossiers, 510(k) (if applicable), and country-specific submissions.
Experience working with Notified Bodies and global regulatory agencies for product approvals and compliance matters.

Nice To Haves

Experience with clinical studies.
Ability to work effectively on project teams.
Must be able to manage multiple and competing priorities and manage programs with minimal oversight.
Strong analytical and problem-solving skills.
Experience with medical device software requirements and software regulations.
Ability to identify risk areas and escalate issues as appropriate.
Prior direct involvement with product development teams.
Good understanding of product development process and design control.
Must be able to write clear, understandable technical documents, i.e. regulatory documentation and scientific presentations.
Experience in assembling facts from various areas, analyzing data, and providing informed recommendations.
Demonstrate knowledge and skills in areas of regulatory pathways, risk-benefit analysis, and quality assurance.
Organized, efficient, process-oriented, high attention to detail.
Effective interpersonal/communication skills.
Supporting products from initial concept through end-of-life phases.
Demonstrated MS Suite proficiency (e.g. Microsoft Word, Excel, Office, PowerPoint, and Adobe).
Regulatory Affairs Certification (RAC).

Responsibilities

Prepare, review, and submit and provide regulatory input and guidance to cross-functional partners regulatory documentation for medical device approvals in compliance with EU MDR, MDSAP, NMPA, TGA, ANVISA, ANMAT, and other relevant regulatory bodies and/or Distributors.
Develop regulatory strategies for new product submissions, modifications, and renewals to ensure compliance with local and international regulations.
Assist with defining the regulatory strategy and manage regulatory submission activities for complex product development activities and product maintenance for existing approved products.
Prepare, submit and maintain regulatory licensing by jurisdictions.
Work cross-functionally with R&D, Quality, Clinical, and Marketing teams to ensure regulatory requirements are met throughout the product lifecycle.
Interface with regulatory agencies to respond to inquiries, deficiency letters, and audits in a timely and professional manner.
Maintain up-to-date knowledge of global regulatory requirements and assess their impact on current and future product approvals.
Support post-market surveillance activities, including adverse event reporting, vigilance reporting, and corrective/preventive actions.
Ensure compliance with labeling, UDI (Unique Device Identification), and registration requirements for applicable markets.
Assist in internal and external audits, including EU MDR, MDSAP, ISO 13485, and country-specific inspections.
Develop and maintain regulatory procedures, work instructions, and training materials.
Provide guidance to junior regulatory team members as needed.
Work with a cross-functional team to provide regulatory support for new product introduction and existing products.
Work with quality, engineers, and technical experts to resolve potential regulatory issues and questions from regulatory agencies.
Create, review and approve change requests.
Interpret new or existing regulatory requirements as they relate to the product portfolio and regulatory and quality system procedures.
Review protocols and reports to support regulatory submissions.
Maintain proficiency in global quality and regulatory requirements.
Demonstrate strong project management, writing, coordination, and execution of regulatory items, with emphasis on technical and scientific regulatory activities.
Provide regulatory input to product lifecycle planning.
Provide support for clinical studies, such as preparing and/or submitting regulatory documents, interaction between sites, support site requests, technical documentation, maintenance of all study files.
Responsibilities may include the following and other duties may be assigned.