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Regulatory Affairs Specialist II Project Management

Company name
Smith & Nephew.

Andover, MA

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Description ABOUT US Smith & Nephew supports healthcare professionals inmore than 100 countriesin their daily efforts to improve the lives of their patients. We do this by taking apioneering approachto the design of ouradvanced medical products and services, by securing wider access to our diverse technologies for more customers globally, and by enabling better outcomes for patients and healthcare systems. We have leadership positions in: \u00b7Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders \u00b7Advanced Wound Management - wound care treatment and prevention products used to treat hard-to-heal wounds \u00b7Sports Medicine - minimally invasive surgery of the joint \u00b7Trauma & Extremities - products that help repair broken bones We have around15,000 employeesaround the world. Annual sales in 2016 were more than $4.6 billion. We are a constituent of the UK's FTSE100 and our shares are\u00a0traded on the London Stock Exchangeand throughAmerican Depository Receipts on the New York Stock Exchange(LSE: SN, NYSE: SNN) SUMMARY: This position is a critical role to ensure the development of operational excellence within Regulatory Affairs. This position has function and cross-function level influence and is generally recognized as an expert resource within the group. The individual must share knowledge and expertise with others in support of all regulatory timelines, activities and SOP development and implementation. The individual will be responsible for leading Regulatory projects as well as representing Regulatory on broader company initiatives.Some regulatory submission work and product strategy may be required. Additional responsibilities include GMP and ISO compliance. The incumbent possesses a good knowledge of domestic and international regulatory\/clinical requirements gained through experience and is able to perform the essential duties and responsibilities with some direct supervision. Travel, both domestic and international, may be required up to 25% of time. ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned. Manage Regulatory projects, including facilitation of Team and Strategy meetings (schedule, prepare\/distribute documentation and ensure action item follow-up; meeting leadership required). Ability to effectively communicate with cross functional teams and motivate a team of busy professionals. Ability to effectively communicate and update senior leadership. Document project milestones\/deliverables and report progress against team, department and corporate goals Facilitate short and long-term planning activities Analyze internal Regulatory Affairs processes, identify opportunities for improvement. Develop departmental and corporate Standard Operating\u00a0 Procedures and departmental manual(s), when necessary. Create cross-functional alignment with key functional areas, including but not limited to Quality, Clinical, Medical and Commercial. Review Federal Register and other sources to identify new regulatory proposals or requirements. Excellent organizational and time management skills needed to manage multiple ongoing projects simultaneously Assists in the development of project specific and departmental budgets. Represents Company in industry associations, standards organizations, and corporate regulatory\/clinical group meetings. Reviews and approves Engineering Change Requests (ECRs) and labeling to insure compliance with FDA and foreign government regulations. Assists in insuring that Company\u2019s record systems, quality control procedures, specifications, etc. comply with FDA and S&N Quality System Requirements (QSRs), corporate standards, or other external standards (ISO 13485) requirements. Other duties as assigned. Qualifications 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 Degree in Engineering with three (3) years experience; or BA or BS in Life Science, nursing, medical technology or related discipline with prior experience of five (5) years in industry-sponsored or academic clinical research. Advanced degree (MBA, MS) preferred. Regulatory Affairs Certification (RAC) optimal. Project Management Certification desirable. LANGUAGE SKILLS: Ability to read, analyze, and interpret general business periodicals, professional journals, technical procedures, or governmental regulations. Ability to write reports, business correspondence. Ability to effectively present information and respond to questions from groups of managers clients, customers and the general public. MATHEMATICAL SKILLS: Ability to calculate figures and amounts such as discounts, interest, commissions, proportions, percentages, area, circumference, and volume. Ability to apply concepts of basic algebra and geometry. REASONING ABILITY: Ability to solve practical problems and deal with a variety of concrete variables in situations where only limited standardization exists. Ability to interpret a variety of instructions furnished in written, oral, diagram, or schedule form. 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, operating computer keyboard approximately 2\/3 or more of the time. Ability to travel by air and motor vehicle both domestically and internationally required. Overnight travel required approximately 40% of the time. Must be able to lift up to 25 pounds. Close vision require to review reports, computer printouts, and operate personal computers. 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.

Company info

Smith & Nephew.
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Company Profile
The Group has a history dating back 160 years to the family enterprise of Thomas James Smith who opened a small pharmacy in Hull, England in 1856. On his death in 1896, his nephew Horatio Nelson Smith took over the management of the business.A few days after the declaration of World War 1 in 1914, Horatio Nelson Smith (the nephew of the company founder T. J Smith) met with an envoy of the French President in London. The company was awarded a contract to supply £350,000 of surgical and field dressings, to be delivered in five months. By the late 1990s, Smith & Nephew had expanded into being a diverse healthcare conglomerate with operations across the globe, including various medical devices, personal care products and traditional and pioneering woundcare treatments. In 1998, Smith & Nephew announced a major restructuring to focus management attention and investment on three business units — wound management, endoscopy and orthopaedics— which offered high growth and margin opportunities.

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