Our client is seeking a Principal Regulatory Affairs Specialist for their Pleasanton, CA location.

OVERVIEW:

As an experienced individual contributor, a Principal Regulatory Affairs Specialist is to provide support for the regulatory department, ensuring efficient and compliant business processes and environment. This position performs 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. Supports necessary regulatory activities required for product market entry.

The individual may execute tasks and play a consultative role by partnering across business functions. The individual may assist in identifying data needed, obtaining these data, and ensuring that they are effectively presented for the registration of products worldwide. The individual may prepare and submit documentation needed for registration worldwide or may oversee such preparation.

SUMMARY:

Develops worldwide strategies for regulatory approval of new and modified products.

Prepares robust regulatory applications for FDA and/or international regulatory agencies to achieve departmental and organizational objectives. Coordinates, compiles, and submits regulatory submissions, including European Dossiers, Premarket Notifications, PMA Supplements, Change Notifications, and other country-specific product registrations.

Represents Regulatory Affairs on cross-functional product development and manufacturing support teams. Guides teams to provide content for submissions and participates in design reviews as needed.

Maintains annual licenses, registrations, and listing information. Assists 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.

Performs other related duties and responsibilities, on occasion, as assigned.

REQUIRED QUALIFICATIONS:

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).

PREFERRED QUALIFICATIONS:

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.