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Principal Regulatory Affairs Specialist (RTI-SPM and ENT) 

adzuna-us  |  United States  |  

United StatesSummer St, MA, 01810
Work Type:
Work Time:
Full Time


Job DescriptionSUMMARY: The RTI Regulatory Affairs member is responsible for supporting, preparing or managing global regulatory strategies for the RTI R&D team for Sports Medicine and ENT franchises.

The incumbent exhibits a broad understanding of Medical Device Regulations.

Provides input for strategic and tactical plans.

The incumbent possesses knowledge of global regulatory requirements gained through experience and is able to perform the essential duties and responsibilities with no direct supervision.

Domestic and international travel may be required up to 40% of time.ESSENTIAL DUTIES AND RESPONSIBILITIES include the following.

Other duties may be assigned.Lead RTI team through assessments of regulatory strategies and risks with minimal delays and costs.

Assure regulatory pre-submissions are prepared and approved to meet the Company’s product launch timelines in all identified markets.

Monitor progress to plan and develop strategies as required.

Manage multiple RTI projects.

Communicate and negotiate with FDA and other regulatory bodies regarding pre-submissions or regulatory pathways.

Maintain a working knowledge of existing and proposed regulations, standards and guidance documents, internal procedures, and facility registration, device listing and import/export requirements.

Build effective partnerships with departments such as Marketing and Development and other global counterparts.

Counsel functional groups to drive strategies based on available information and regulatory considerations.

Assure compliance with all global medical device laws and regulations.

Provide analysis of impact and comments on new regulatory requirements and national and international standards.

Advise on adjustments to company procedures and design requirements as necessary.OTHER JOB FUNCTIONS these are non-essential job duties and responsibilities as assigned by the supervisor.Develop, review and approve departmental and corporate policies and procedures and departmental procedures, when necessary.

Development of project specific and departmental budgets.

Represent Company in industry associations, standards organizations, and regulatory group meetings of strategic important to Smith & Nephew.

Other duties as assigned.QUALIFICATION REQUIREMENTS: 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.

Master’s degree desired.

Extensive knowledge of FDA and applicable international regulations required.

Minimum of 6-7 years of medical device submission experience is preferred.

Class II and III Medical device experience desired.

Direct work experience in another regulated industry or like discipline may be considered.

Experience managing projects required.

In-depth experience in dealing with FDA and international medical device regulatory agencies required.DESIRED SKILLS:Excellent English written and verbal communication skills including one-on-one and group presentation skills, Microsoft Office application skills, self motivated, attention to detail, able to prioritize and manage multiple projects.

Able to lead projects with no direct supervision.

Able to effectively communicate with government agencies and all levels of the company.

Good problem solving, planning, interpersonal and negotiating skills.LANGUAGE SKILLS: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.MATHEMATICAL SKILLS: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.REASONING ABILITY: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.PHYSICAL DEMANDS: 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.WORK ENVIRONMENT: 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.Full time