Director, Regulatory Affairs

Volcano Corporation provides rewarding and challenging employment opportunities for those qualified and selected individuals wishing to join us as we develop, market, and manufacture products that improve the overall quality of medical care.

Come join Volcano Corporation - a team leading the way!

JOB SUMMARY:

To develop and execute product approval regulatory strategies for product development teams.   Ensure compliance with all applicable domestic and international standards and regulations that pertain to regulatory approval and maintenance on the market; interpreting regulations and guidelines; prepare and execute regulatory plans; represent the Regulatory Affairs department and provide guidance while participating on cross functional medical development teams.   Develop, review and approve product labeling and literature, advertising and promotional materials.  Ensure that overall regulatory activities are conducted and documented in accordance with US FDA requirements and guidelines, applicable international requirements and guidelines, and company procedures.

RESPONSIBILITIES:

• Develop strategies for product submissions/registrations in accordance with current worldwide regulations and guidelines.


• Reviews and approves product release status for new products.


• Prepare and oversee as necessary the preparation of all FDA submissions; 510K’s, IDE’s, PMA’s, etc.


• Prepare and oversee as necessary the preparation of all European registrations for new or modified products; CE marking , design/technical dossiers, etc.


• Prepare and oversee as necessary the preparation of Japanese product submissions.


• Maintains technical reports & certifications from all regulatory agencies.


• Oversee various compliance activities / processes as needed including employee training on regulatory topics.


• Develop and manage process for advertising and promotion product claims made, assist with developing/sourcing supportive documentation for the review and approval of labeling decisions, documents, advertising and promotional literature; some of which may be used as part of the marketing application to regulatory authorities.; insure conformity and compliance with approved claims.

EDUCATION:

Bachelor’s degree in Health Sciences, Biomedical engineering or related field required. Master’s degree desirable.

KNOWLEDGE AND EXPERIENCE:

• A minimum of fifteen (15) years in the regulatory affairs field, four to six (4-6) of these years must be experience at a manager-level.


• Medical device experience a must; US 510K and PMA submissions


• European CE marking experience.  Class III design dossier and Class IIa/IIb Technical File


• Japanese MHLW/Shonin regulatory process.

ADDITIONAL DESIRABLE QUALIFICATIONS:

Regulatory Affairs Certification (RAC).

SKILLS AND ABILITIES: 

• Well-developed organizational skills required


• Advanced written and verbal communication skills


• Previous practical experience in regulatory activities in cardiovascular medical device applications highly desirable


• Proficiency in Microsoft Office Suite, particularly Word and Excel


• Personnel management


• Project management.

PROBLEM SOLVING AND DECISION MAKING:

• Assessing an appropriate regulatory path based upon global business strategies.


• Regulatory solutions taking financial responsibility into account


• Regulatory solutions with consideration and guidance relative to impacts to operations and manufacturing.

PHYSICAL REQUIREMENTS: 

• Ability to hear and speak to employees and outside business associates on the phone and in person


• Ability to see the letters and numbers on a personal computer screen and on memos, reports and other documents (near vision)


• Requires moderate right and left hand coordination for the use of the personal computer. 

SUPERVISORY RESPONSIBILITY: 

• RA Associate


• RA Assistant


• Project Teams

TRAVEL REQUIREMENTS: 

• International travel to Japan and Europe at least quarterly


• US travel as necessary for meetings, seminars, training and conferences.