Senior Regulatory Affairs Specialist

Summary

This onsite position is responsible for performing activities related to compliance of products and monitoring of company’s conformance to applicable regulatory requirements.  Supports product development and completes global regulatory submissions in connection with the marketing of products.  This position requires maintaining knowledge and understanding of the applicable regulations and harmonized standards. 

Essential Functions

Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.

• Supports the organization in ensuring that the company maintains compliance to regulatory requirements, the established quality system requirements.
• Participates in internal and external audits and inspections, including follow-up activities, as required.
• Participates and provides input into the risk management process, including product risk assessments, benefits analysis, and reports throughout the product life cycle, as required.
• Completes recall, MDR, and advisory notice activities to ensure appropriate monitoring and reporting in accordance with established procedures and plans
• Provides regulatory guidance and inputs to departments or development project teams regarding design and development, change control, testing, labeling, and marketing of products.
• Performs and maintains registration and product listing/licensing with regulatory agencies, and renewal of pertinent business licenses, as required. This is includes providing support and required documentation to authorized representatives and distributors where necessary to complete the registration.
• Reviews and approves product labeling such as product labels, data sheets, user manuals, safety data sheets, and promotional materials 
• Participates in conducting company-wide compliance training, as needed.
• Generates Technical Documentation, where required, including but not limited to preparing regulatory plans, clinical evaluations, and post-market reports.
• Provides regulatory support and participates in CAPAs as needed.
• Keeps up to date with changes in regulatory legislations that may impact the company and performs gap analysis, as necessary.
• Develops and reviews SOPs as needed to ensure regulatory compliance.
• Completes and supports regulatory submissions (e.g. 510(k) etc.) and product registration in accordance with established regulatory strategies and plans
• Maintains required documents, such as Certificates to Foreign Government (CFG), as required.
• Facilitates custom clearance, including generating documentation as required.
• Other duties as assigned by Management.

Competencies

• BS/BA Degree with five (5) years working in pharmaceutical or medical device industry or MS Degree with 3 years of relevant experience.
• Strong oral and written communication skills.
• Willing to set and drive aggressive project timelines.
• Capable of strategic thinking and proposing solutions to regulatory problems.
• Attention to detail and good organizational skills.
• Problem solving and investigative skills.
• High level of reading comprehension.
• Demonstrates independent judgment within broadly defined policies and ability to lead multiple projects.
• Strong computer and internet research literacy.
• Knowledge of FDA/EMEA, ISO/GMP.

Expected Location & Hours of Work

• Onsite - Pacheco, CA
• 8 a.m. to 5 p.m. Monday – Friday. This position may require working extended weekday or weekend hours depending on business needs.

Compensation Range

• $120,000 - $130,000 annually