The Senior Regulatory Affairs Specialist is responsible for preparing US and international regulatory submissions and regulatory strategies.
The incumbent possesses knowledge of regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision. Domestic and international travel may be required up to 25% of time.
ESSENTIAL DUTIES AND RESPONSIBILITIES:
Prepare global regulatory submissions such as; 510(k), PMA, European dossier, Japanese STED and others as necessary for new and modified devices.
Work closely with project teams to develop regulatory strategies, testing requirements and other documentation to assure that regulatory submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.
Communicate with FDA and other regulatory bodies regarding submissions.
Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.
Maintain computer database to insure only cleared products are released for sale.
Review and approve engineering change requests for design, manufacturing and labeling changes to insure compliance with FDA and international government regulations.
Review package inserts (labeling) and promotional materials to insure compliance with FDA and international requirements.
OTHER JOB FUNCTIONS:
Development of departmental and corporate Standard Operating Procedures and departmental procedures, when necessary.
Assist in the development of project specific and departmental budgets.
Represent Company in industry associations, standards organizations, and corporate regulatory/clinical group meetings.
Other duties as assigned.
To perform this job successfully, an individual must be able to perform each essential duty satisfactorily. The requirements listed below are representative of the knowledge, skill, and/or ability required. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
EDUCATION and/or EXPERIENCE:
Bachelor’s degree in Engineering or life sciences preferred, but other degrees may be considered. It is preferred for candidate to have a minimum of 3-5 years of regulatory submissions experience in the medical device industry, or direct work experience in a regulated industry or like discipline. Orthopaedic device experience desired.
Extensive knowledge of FDA and applicable international regulations required.
Excellent English written and verbal communication skills including presentation skills, Microsoft Office application skills, self-motivated, attention to detail, able to prioritize and manage multiple projects. Able to lead projects with minimal supervision.
Ability to read, analyze, and interpret regulations, technical standards, guidance documents, test reports, clinical and medical terminology and complex documents.
Ability to respond to inquiries and complaints from customers and regulatory agencies. Ability to write detailed technical regulatory submissions, reports and business correspondence.
Ability to effectively present information to other employees, management and regulatory agencies.
Ability to compute ratio, percent and draw and interpret raw data into graphical representations.
Ability to convert English units into metric units and vice versa.
Ability to comprehend and apply principles of algebra, statistics, calculus and mathematical operations used in various engineering and clinical analysis.
Ability to interpret a variety of instructions furnished in written, oral, diagram or schedule form. Ability to define problems, collect data, establish facts and draw valid conclusions.
Ability to apply principles of logical or scientific thinking to a wide range of intellectual and practical problems. Ability to deal with a variety of abstract and concrete variables.
The physical demands described here are representative of those that must be met by an employee to successfully perform the essentials function of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires sitting, talking or listening, more than 2/3 of the time. Walking or standing less than 1/3 of the time. Use of hands to use computer or write documents less than 2/3 of the time. Ability to travel by air and motor vehicle both domestically and internationally required. Some overnight travel required. Searching for, lifting and carrying records weighing up to 25 pounds less than 1/3 of the time. Close vision (clear at 20 inches or less) required to review documents and operate personal computers more than 2/3 of the time.
The work environment characteristics described here are representative of those an employee encounters while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
Requires working most of the time in an office setting.
SCOPE OF POSITION RESPONSIBILITIES:
For Funds, Costs, or Profits: No direct responsibility for funds, costs, or profits except for guidance in meeting departmental budget objectives.
For Supervision: May assist or offer guidance to other regulatory staff. May oversee some duties of lower level Regulatory Specialists as assigned.
For Internal and External Relationships: Extensive contact required with other departments. Primarily interacts with Marketing, Product Development, Quality Assurance, Manufacturing, Materials Management, Distribution, Purchasing, GIS, Package Development, Sales, Legal, Clinical Affairs and Research.
For Organization Influence: Influences decisions for domestic and international regulatory/clinical filings, and GMP and ISO compliance.
Limits of Authority: Responsible for ensuring work is performed to high standards. Decisions made other than routine decisions on product registration filings are made in consultation with or deferred to Regulatory Management.
Smith and Nephew is an Equal Opportunity/Affirmative Action Employer. Employment decisions are made without regard to race, color, religion, national or ethnic origin, sex, sexual orientation, gender identity or expression, age, disability, protected veteran status or other characteristics protected by applicable law.
Smith & Nephew is a diversified advanced medical technology business that supports healthcare professionals in more than 100 countries to improve the quality of life for their patients. We have leadership positions in Orthopedic Reconstruction, Advanced Wound Management, Sports Medicine and Trauma:
• Orthopedics Reconstruction - joint replacement systems for knees, hips and should...ers
• Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds
• Sports Medicine - minimally invasive surgery of the joint
• Trauma & Extremities - products that help repair broken bones
We have over 15,000 employees around the world. Annual sales in 2015 were more than $4.6 billion.
We are a constituent of the UK's FTSE100.