Senior Regulatory Affairs Specialist

The Senior Regulatory Affairs Specialist is charged with coordinating, preparing, and maintaining regulatory submissions and documents on a global level for Europe, the United States, and other countries. The position is also responsible for providing regulatory support to assure compliance for current products and processes. The Senior RA Specialist interacts closely with regulatory agencies and routinely submits 510(k), PMA, IDE, and CE-mark declarations of conformity as appropriate.

Other responsibilities include identifying relevant standards and guidance documents that affect the company's business and products, assisting with FDA facility inspections and notified body audits and making MDR or Vigilance report recommendations as appropriate.

- Determines global regulatory pathways for various projects including product classification and type of regulatory submission or rationale required.

- Participates on project teams to define regulatory requirements of U.S. and international submissions, technical files or regulatory rationales.

- Identifies guidance documents, international standards and consensus standards and assists teams with their interpretation.

- Prepares regulatory submissions to the FDA, the competent authorities and other regulatory authorities.

- Prepares for pre-IDEs meetings and assists with clinical trials when required.

- Interacts with various levels of management, external agencies and companies.

- Analyzes and makes recommendations regarding complaints received by the company and whether they are MDR or vigilance reportable; participates in complaint investigations and CAPA meetings as appropriate.

- Provides regulatory training when needed.

- Acts as liaison with appropriate local, national and international regulatory authorities.

- Provides regulatory guidance to sales, marketing, and manufacturing groups, as appropriate, for both onsite and remote activities.

- Reviews changes in manufacturing facilities, manufacturing procedures, and analytical methods.

- Identifies and monitors schedules for submission documentation, documentation review, protocols and reports; prepares additional written materials as needed.

- Prepares responses to FDA letters, supplements, and amendments; participates in ISO and customer audits and FDA inspections and presentations.

- Writes standard operating procedures as needed.

- Provides input for the preparation of the departmental budget; ensures that the department operates within capital and expense budget guidelines.

- Keeps informed of new regulations, standards, policies, and guidance issued by relevant regulatory authorities that may impact the company.

- Performs other related duties and tasks, as required.
Qualifications:
- Education and experience equivalent to a bachelor's degree in the biological, chemistry, physical, engineering or material science disciplines and six years of related experience.

- Demonstrated knowledge of U.S. FDA regulations, the In Vitro Diagnostic Devices Directive (98/79/EC), and various quality system standards/regulations/laws, including ISO 13485, QSR, etc.

- Self-motivated, self-directing, strong attention to detail and excellent time management skills.

- Strong interpersonal skills and the ability to communicate well - verbally and in writing - with others.

- Demonstrated computer skills preferably spreadsheets, word processing, database, internet research and other applicable software programs.

- Multi-lingual skills are beneficial.