Regulatory Affairs Specialist

4 weeks ago

Pleasanton, California, United States Accordance Search Group Full time
Job Title: Principal Regulatory Affairs Specialist

We are seeking a highly skilled Principal Regulatory Affairs Specialist to join our team at Accordance Search Group. As a key member of our regulatory department, you will play a critical role in ensuring the efficient and compliant business processes and environment.

Key Responsibilities:
  • Provide support for the regulatory department, ensuring efficient and compliant business processes and environment.
  • Perform specialized level work assignments and/or analyses, evaluation, preparation, and submission of documentation for the worldwide regulatory registration, ensuring products and procedures comply with regulatory agency specifications.
  • Support necessary regulatory activities required for product market entry.
  • Develop worldwide strategies for regulatory approval of new and modified products.
  • Prepare robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives.
  • Coordinate, compile, and submit regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.
  • Represent Regulatory Affairs on cross-functional product development and manufacturing support teams.
  • Maintain annual licenses, registrations, and listing information.
  • Assist with compliance to product post-marketing approval requirements.
  • Subject Matter Expert (SME) for audits and inspections by internal teams or external regulatory authorities.
  • Reviews, edits, and approves Advertising and Promotional materials.
  • Acts as liaison between the Company and in-country affiliates as well as the various regulatory agencies, ensuring that communications are relevant, specific and convey all necessary detail.
  • Maintains ongoing surveillance and analysis of all pertinent medical device regulations to ensure submission requirements worldwide are current, up-to-date and are entered into the regulatory submission database and file systems.
  • Ensures that details of any new or modified regulations are distributed to appropriate team members.
  • Supports the product implementation process by creating database (GTS) licenses or reviewing and approving requests for product release.
  • Interfaces directly with regulatory agencies as needed.
  • Conducts reviews of product and manufacturing changes for compliance with applicable regulations.
  • Communicates with and maintains productive, constructive relationships with external customers as required – regulatory authorities, Notified Bodies, in-country affiliates, and/or distributors.
  • Support Department and Company initiatives as identified by management and in support of Quality Management Systems (QMS), Environmental Management Systems (EMS), and other regulatory requirements.
  • Complies with US Food and Drug Administration (FDA) and international regulations, other regulatory requirements, company policies, operating procedures, processes, and task assignments.
  • Maintains positive and cooperative communications and collaboration with all levels of employees, customers, contractors, and vendors.
Requirements:
  • Bachelor's Degree in Scientific discipline e.g. Chemistry, life Sciences, Biology (or equivalent vocational qualifications)
  • Experienced in regulatory submissions for Pharmaceutical, in vitro diagnostic devices and/or medical devices.
  • Experience of working within the requirements of 21 CFR 820, ISO 13485, the Medical Devices Directive (93/42/EEC) and/or the IVD Directive (98/79/EC).
  • Minimum of 5 years' experience working with Class II and/or Class III medical devices. Regulatory Affairs Certification (RAC) is a plus.
  • Experience with either 510(k) applications, PMA supplements and US device regulations, or with EU and other international medical device regulations and submissions.
  • Must be familiar with relevant regulatory requirements for medical devices including Quality Systems standards and clinical investigations.
  • Experience with word processing, spreadsheet, and presentation graphic software packages.
  • Experience working in a broader enterprise/cross-division business unit model.
  • Ability to work in a highly matrixed and geographically diverse business environment.
  • Ability to work within a team and as an individual contributor in a fast-paced, changing environment.
  • Ability to leverage and/or engage others to accomplish projects.
  • Ability to identify, solve problems, and work independently with little oversight.
  • Strong verbal and written communications with ability to effectively communicate at multiple levels in the organization.
  • Multitasks, prioritizes, and meets deadlines in a timely manner.
  • Strong organizational and follow-up skills, as well as attention to detail.
  • Ability to travel approximately 5%, including international travel.
  • Ability to maintain regular and predictable attendance.

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