SPIRATION, Inc.
Olympus Respiratory America
Job Description
JOB TITLE:
Executive Director, Regulatory Affairs
DEPARTMENT:
Regulatory Affairs
JOB FAMILY/JOB GROUP/GRADE:
Regulatory
IMMEDIATE SUPERVISOR:
President and CEO
SUMMARY (PRIMARY FUNCTIONS): Responsible for directing all regulatory affairs activities.
Develops and implements regulatory strategies for the earliest possible clinical study and product
approvals. Ensures the timely creation, preparation, and achievement of organized and scientifically valid
regulatory and clinical trial submissions.
INTERNAL AND EXTERNAL CUSTOMER CONTACT: Interfaces internally with Spiration, Inc.
executive staff, the management team, employees, and Olympus affiliate staff regarding regulatory
strategies, submissions, and status. Interacts externally with US and international regulatory agency
personnel, consultants (regulatory, medical, statistical, clinical and quality), clinical study site
personnel, quality system auditors, and Notified Bodies.
RESPONSIBILITIES:

Develop and implement regulatory plans and strategies with the executive team and outside
consultants for Spiration products including US and international clinical studies, product registrations
and export approvals.

When assigned, develop regulatory plans and strategies with the executive team and outside
consultants for Olympus products including US and international clinical studies, product registrations
and export approvals.

Provide project team, department, and executive guidance, interpretation, and training based on
current regulatory affairs requirements, regulations, and processes; provide also for external
personnel, as required.

Create, prepare, and submit organized and scientifically valid regulatory and clinical trial submissions
in the US (IDE, PMA, 510(k), HDE) and assist with OUS (submissions to Ethics Boards, Health
Authorities, and Notified Bodies).

Build a strong rapport and interface with regulatory agencies.

Draft, review/understand, and/or approve: regulatory plans, operating procedures and work
instructions, clinical investigational plans, clinical reports, investigator brochures, informed consent,
instructions for use, case report forms, clinical recruitment documents, presentations, change
summaries, product labeling and technical documentation, quality system/manufacturing
documentation, verification/validation documentation, risk management documentation, and
marketing/promotional material.

Review and approve all controlled document changes for content, associated regulatory impact, and
regulatory risk.

Create and ensure the organization and maintenance/archive of paper and electronic internal
regulatory documents (correspondence, regulatory submissions/approvals, and regulatory
documents). Monitor the organization and maintenance/archive of internal paper and electronic
clinical documents in order to authorize initial clinical shipments to sites.

Manage and facilitate activities of the CEC and DSMB committees for clinical studies (Adverse Event
tracking/summaries, material preparation, meeting scheduling/facilitation, writing meeting minutes,
tracking member contracts, approving/processing invoices).
Executive Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
Page 1 of 2
Rev140715

Monitor clinical trial compliance in areas of safety, deviations, clinical trial master files, and site
monitoring.

Develop and manage Regulatory Affairs financial budget, forecast changes, and invoicing activity.

Hire, train, mentor and supervise department staff involved in Regulatory Affairs activities and
submissions.

Obtain current, relevant regulatory information (i.e. guidances, CFR references, etc.), distill the
important sections that apply to the company, and recommend how the company should comply.

Manage and take responsibility for outside consultants and contractors that directly relate to job
responsibilities (communication, scheduling, project status, and budgets/invoices).

Perform other duties as necessary and assigned.
QUALIFICATIONS
Skills:
 BA or BS degree in science, engineering or related field. Advanced degree optimal.
 Minimum of 20 years progressively responsible US and international regulatory affairs experience in a
medical device industry required. Class III device, clinical study and hands-on advanced quality
systems experience also required.
 RAC, CQA, and CQM a plus.
 Sophisticated knowledge of and experience with FDA medical device regulations and guidance,
Medical Device Directive (93/42/EEC) and guidance, Good Clinical Practices guidance, ISO 13485
Quality System standards, and other applicable US and international regulations, guidances, and
standards required.
 Successful experience with the origination 510(k), IDE, HDE, and/or PMA submissions also required.
 Must have experience in setting up/supporting multicenter medical device clinical trials, clinical FDA
audits (BIMO), quality system development/implementation and both internal and 3rd party/FDA
audits.
 Excellent team building and people-management skills necessary.
Ability to:
 Create strong, effective working relationships with the FDA and outside consultants.

Be a self-motivated and results-oriented individual.

Instill a proper degree of discipline and quality.

Provide product regulatory direction to product development teams to achieve successful product
introductions.

Work effectively with all levels of staff.

Communicate regulatory requirements and issues effectively within the Company, and with outside
agencies and customers.

Act as a role model within and outside the Company.
PHYSICAL GUIDELINES
This position works indoors in a general office environment. Frequent telephone and computer use at
a workstation and frequent walking and sitting for long periods throughout the workday. May lift boxes
up to 25lbs, push and pull carts up to 50 lbs. Will travel domestically and internationally approximately
10% of the time.
Executive Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
Page 2 of 2
Rev140715