Sr Regulatory Affairs Specialist

4 hours ago

Brea, United States Acara Solutions, An Aleron Company Full time

Acara Solutions is looking for a Sr. Regulatory Affairs Specialist in Brea, CA. This position is a contract position lasting 6-8 months.


Pay: $45 hourly


Position Overview:

The Sr. Regulatory Affairs Specialist creates, evaluates, and completes regulatory tasks related to the following: worldwide product registration submissions, facility registrations, technical files, FDA submissions, special projects, and strategy to drive market growth worldwide. This individual is responsible for obtaining global regulatory clearances/approvals based on company objectives, attending product development meetings, regional alignment; as well as collaborating with cross-functional departments to ensure country-specific requirements are met and integrated throughout the design control and post-product launch activities. This position will be based at our HQ in Brea, CA and will require someone work on-site 3x per week.

ESSENTIAL DUTIES AND RESPONSIBILITIES:

  • Assist in the development of RA strategy for new products and design changes - ensuring regulatory requirements for target markets are met.
  • Actively participates in defining customer requirement, product claims and target markets early in the product development lifecycle.
  • Prepare and maintenance technical files, MDD/MDR certifications and declarations of conformity in support of EU product registrations/CE mark.
  • Maintains current knowledge of relevant regulations, including proposed and final rules issued by relevant regulatory authorities that may impact the company
  • Creates and implements regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced
  • Technical writing of procedures and/or SOPs that link to the regulatory operations
  • Represents and provides regulatory guidance within the cross-functional team and serves as the expert in regulatory affairs for new product development/sustaining projects
  • Develops and coordinates regulatory strategies and regulatory plans
  • Responsible for the implementation of regulatory strategies and ensures timely registration of products in compliance with applicable regulations and guidance through coordination and preparation of submission documents for the registration of new products and existing products in regulated markets (i.e. US, Canada, Asia-Pac, LATAM, Russia/CIS, China, and MEA-T)
  • Prepares documentation that is complete, accurate, and on time.
  • Coordinates, prepares, and maintains regulatory submissions, product clearances/approvals, certifications, facility registrations, tender support, etc., according to country registration requirements to facilitate product approvals in all regions
  • Work directly the regions (inter-company partners, distributors, in-country consultants, commercial partners, etc.) to fulfill regulatory requirements for product registration purposes
  • Maintains approvals/licenses/authorizations for existing marketing authorizations
  • Complete regulatory assessments and audits of product, manufacturing, Quality Management System (QMS) and labeling changes to assess impact to the user/patient, regulatory reporting, and compliance to regulations
  • Manage regulatory projects consistent with the company goals
  • Identifying, communicating, and solving any regulatory issues that may arise


JOB REQUIREMENTS:

  • Bachelor's degree in a scientific discipline
  • 4-6 years of work experience in RA role within Medical Device industry or 2 years work experience with Master's Degree

SKILLS & QUALIFICATIONS:

  • Master's degree in Regulatory Science or RAC certification preferred
  • Experience authoring 510(k)s, PMA, Health Canada and/or EU Technical File submissions for medical devices preferred
  • Demonstrated experience serving as lead RA representative on cross-functional teams supporting new product development; SaMD experience a plus.
  • Must possess in-depth knowledge of design control requirements and experience assessing product and/or manufacturing changes for regulatory impact
  • Experience reviewing and approving marketing, advertising, and promotional materials a plus.
  • Successfully manage multiple projects simultaneously and within a fast-paced environment
  • Problem-solving skills and creativity
  • Works well in a cross-functional team; will speak up to provide regulatory guidance
  • Solves complex problems; takes a new perspective on existing solutions; exercises judgement based on the analysis of multiple sources of information
  • Enjoys being a resource for colleagues with less regulatory affairs experience
  • Organizational problem-solving skills, project coordination skills and computer literacy in Microsoft Office suite
  • Enthusiastic self-starter
  • Excellent verbal, written, and interpersonal skills (explains difficult or sensitive information; works to build consensus)
  • Must be comfortable dealing with ambiguity, relying on critical thinking to accomplish project goals
  • Highly organized with a detail-oriented mindset
  • Portray flexibility and multi-tasking in a dynamic environment with changing priorities
  • Interpret and provide guidance on regulations from various countries
  • Read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals
  • Write routine reports and correspondence

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