SPIRATION, Inc.
Olympus Respiratory America
Job Description
JOB TITLE:
Director/Executive Director of Regulatory Affairs
SUMMARY (PRIMARY FUNCTIONS): Responsible for directing all regulatory affairs activities for
Spiration. 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, and employees 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.
DUTIES AND RESPONSIBILITIES:
1. Develops and implements regulatory strategies and plans for US and international clinical studies,
product, and export approvals with the executive team and outside consultants.
2. Provides 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.
3. Creates and submits organized and scientifically valid regulatory and clinical trial submissions in the
US (IDE, PMA, 510(k), HDE) and assists with OUS submissions to Ethics Boards, Health
Authorities, and Notified Bodies.
4. Builds a strong rapport and interfaces with regulatory agencies.
5. Drafts, reviews/understands, and/or approves; 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.
6. Reviews and approves all controlled document changes for content, associated regulatory impact,
and regulatory risk.
7. Creates the systems and ensures the organization, maintenance and preservation of paper and
electronic internal regulatory documents.
8. Manages and facilitates activities of the CEC and DSMB committees for clinical studies (adverse
event tracking and summaries, material preparation, meeting scheduling/facilitation, writing meeting
minutes, tracking member contracts, approving/processing invoices).
9. Monitors clinical trial compliance in areas of safety, deviations, clinical trial master files, and site
monitoring.
Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
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Rev. 11.15.13
10. Develops and manages Regulatory Affairs’ financial budget, forecast changes, and invoicing activity.
11. Hires, trains, mentors and supervises department staff involved in Regulatory Affairs activities and
submissions.
12. Obtains current, relevant regulatory information (i.e. guidances, CFR references, etc.), distills the
important sections that apply to the company, and recommends how the company should comply.
13. Manages outside consultants and contractors that directly relate to job responsibilities
(communication, scheduling, project status, and budgets/invoices).
14. Performs other duties as necessary and assigned.
QUALIFICATIONS:
Education:
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Bachelors Degree or equivalent required.
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Emphasis in science, engineering or related fields optimal.
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Advanced degree a plus.
Experience:
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15+ years progressively responsible US and international regulatory affairs experience required.
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5+ years in the medical device industry working with Class III devices, clinical studies, and
advanced quality systems also required.

Hands-on experience with PMA submissions also required.
Certification/License Needed:

RAC, CQA, and CQM preferred.
Skills:
 Thorough knowledge of FDA medical device regulations and guidance, Medical Device Directive
(93/42/EEC) and guidance, Good Clinical Practices guidance, ISO 13485 Quality System standard,
and other applicable US and international regulations, guidances, and standards.
 Must have experience in implementing the above regulations, standards, and guidances in the
medical device industry.
 Must have successful original 510(k), IDE, HDE, and PMA submissions experience.
 Must have experience in setting up/supporting multicenter medical device clinical trials.
 Must have experience in clinical FDA audits (BIMO).
 Must have experience in quality system development/implementation and both internal and 3 rd
party/FDA audits.
 Must have experience in managing and facilitating development of regulatory staff.
 Good knowledge of product and process development, verification, and validation.
 Proficient in timely review of technical and clinical data.
 Superior writing, composition, English grammar and proofreading skills required.

Sophisticated skills in Microsoft Word, Outlook, Excel and PowerPoint required. Access, Visio, and
MS Project skills desirable. Desktop publishing or experience with creation and editing of large,
multi-format MS Word documents also highly desirable.
Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
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Rev. 11.15.13
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Excellent verbal communication skills necessary. At ease approaching and interacting with highly
educated, sophisticated professionals such as hospital and clinical site professionals.

Possesses a critical eye for both form and function.

Demonstrated ability and aptitude working with numbers (math), databases and spreadsheets.

Prior experience developing and following systems for organizing and maintaining large volumes of
records, data and materials required.

Superior analytical and problem solving skills.

A proven record of consistently following through on commitments. Maintains and communicates realistic
schedules and meets or beats deadlines.
 Exceptional collaboration skills with previous experience interacting crossfunctionally with executive, engineering, quality, regulatory, and clinical research
teams
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Other Skills:
* Strong mathematical and analytical skills required.
* Superior project coordination, organizational and problem-solving skills,
proven record of consistently following through on commitments.
 * Team-focused, self-motivating and passionate for innovation and high quality
work
 * Demonstrates the highest ethical standards, actively promotes trust, respect
and integrity in all dealings both inside and outside the Company.
 * Proven ability to work independently - self-directing, self-motivating and an
independent thinker.
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 Excellent team building, interpersonal skills.
 Strong analytical, problem solving and organizational skills.
 Project management and team leadership skills
 Training design, development, and delivery skills
 Effective strategic and negotiation skills
 Accomplish multiple assignments simultaneously
Ability to:
 Be a self-motivated and results-oriented individual
 Demonstrate strong, effective working relationship with FDA and outside consultants
 Instill 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
Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
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Rev. 11.15.13
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Strong customer service, interpersonal and
relationship-building skills
Alternative to minimum experience/education preferred: N/A
PHYSICAL GUIDELINES: (This position does not require lifting over 20 lbs.)
Approvals:
Employee's Signature
Date
______________________________________________
Supervisor/Manager's Signature
Date
Human Resources Manager
Date
Director, Regulatory Affairs
Spiration, Inc.-Olympus Respiratory America
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Rev. 11.15.13