Sr. Regulatory Affairs Specialist

Caldera Medical; Westlake Village (CA); On-site; USD 90,000 - 120,000; Full time

Benefits offered by this job

Medical and Dental Benefits

Vision Coverage

401(k) with matching contributions

Unlimited Vacation Policy

6 Weeks Paid Maternity Leave

Job summary

Caldera Medical is looking for a Senior Regulatory Affairs Specialist to manage regulatory documentation for medical device approvals. This role involves developing regulatory strategies and preparing submissions for compliance with various international regulations.

The ideal candidate will have 5-7 years of experience in regulatory affairs within the medical device industry, alongside a Bachelor's or Master's degree in a relevant field. Benefits include medical and dental coverage, 401(k) with matching contributions, and unlimited vacation.

Qualifications

• 5-7 years of regulatory affairs experience in the medical device industry.
• Proven experience in preparing regulatory submissions such as Technical Files and CE Marking dossiers.
• Experience working with Notified Bodies for product approvals.

Responsibilities

• Prepare, review, and submit regulatory documentation for medical device approvals.
• Develop regulatory strategies for new product submissions.
• Maintain knowledge of global regulatory requirements.

Skills

Experience with clinical studies

Analytical and problem-solving skills

Strong understanding of EU MDR

Effective interpersonal/communication skills

Proficiency in MS Suite

Education

Bachelor’s or Master’s degree in Regulatory Affairs, Life Sciences, Biomedical Engineering

Job description

Sr. Regulatory Affairs Specialist

100% ON SITE in Westlake Village, California. Sponsorship is not available for this role.

Responsibilities

• Prepare, review, and submit 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.

Desired Knowledge, Skills and Abilities

• 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).

Required Knowledge, Skills and Abilities

• 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.

Benefits

• Medical and Dental Benefits
• Vision Coverage
• 401(k) with 4% matching contributions after 90 days of employment
• Basic Life and AD&D
• Unlimited Vacation Policy
• 6 Weeks Paid Maternity Leave
• 10 paid holidays
• Being surrounded by amazing people!

Caldera Medical is an equal opportunity employer and considers all candidates for employment regardless of race, color, religion, sex, national origin, citizenship, age, disability, marital status, military or veteran's status (including protected veterans, as may be required by federal law), sexual orientation, gender identity or any other category protected by law.