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Job Details

Regulatory Affairs Specialist I 510K Submissions-Medical Device

Company name
Smith & Nephew.

Location
Pittsburgh, PA

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Regulatory Affairs Specialist I (510K Submissions)-Medical Device','R22588','!*!

ABOUT US

Smith & Nephew supports healthcare professionals in more than 100 countries in their daily efforts to improve the lives of their patients.  We do this by taking a pioneering approach to the design of our advanced 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:

·         Orthopaedics Reconstruction - joint replacement systems for knees, hips and shoulders

·         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 around 15,000 employees around 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 traded on the London Stock Exchange and through American Depository Receipts on the New York Stock Exchange (LSE: SN, NYSE: SNN)

SUMMARY

Under a limited degree of management supervision and direction, prepares global regulatory strategies and coordinates associated registration or submissions leading to market clearance/approval.  Provides regulatory direction to project teams for product development/design control related activities.  Assesses various change notices for regulatory submission impact.  Develops product labeling, including IFUs (Instructions for Use).

ESSENTIAL FUNCTIONS

Coordinates and prepares regulatory submissions (e.g., 510k’s, PMA’s, CE Technical Files, international registrations) leading to timely market introduction.

Actively participates on product development teams to provide general direction related to the registration review process/timelines, design control, labeling and other associated regulatory requirements/guidance’s. 

Prepares regulatory strategy for key global markets as part of project teams in support of new product development activities.  Able to identify key obstacles posed by project and offers viable solutions that meet regulatory requirements.

Monitors activities of applicable regulatory agencies and industry organizations to identify any changes in regulations. 

Reviews and assesses change notices (e.g., ECN’s) for impact on existing and required product submissions and registrations. 

Develops product labeling content, including Instructions for Use, in coordination with key stakeholders (product development teams, marketing, R&D, QA, labeling specialists, etc.).','!*!REQUIREMENTS

Travel 0-25% (may frequently involve overnight and/or multi-day travel)

Education     

Requires a Bachelor’s Degree (preferably in a clinical, medical, scientific/technical or legal discipline)

Licenses/Certifications      

RAC desirable (Regulatory Affairs Certification-Regulatory Affairs Professional Society)

Experience   

5 years of prior related medical device industry experience or equivalent

Competencies 

Demonstrates a solid, fundamental understanding of medical terminology, anatomy, regulations, standards and technical concepts.

Able to work and problem solve both independently and as part of a team.

Able to work within deadlines as imposed by government regulations and internal guidelines.

Able to handle multiple tasks/projects and demonstrate flexibility in managing changing priorities.

Able to read, understand, and apply regulations to activities.

Requires a high level of computer proficiency (Adobe, MS Office, etc.).•           Possesses appropriate verbal and written communication skills for interacting with internal and external stakeholders. Other 

 Knows and adheres to the quality policy of the company and the quality-related procedures and instructions

Reports any deviation in product or process, of which he/she becomes aware, to his/her manager or the Quality department

Completes all necessary training in the area of Quality and GMP (Good Manufacturing Practice)

Immediately reports any dissatisfaction or complaint which is brought to their attention from a customer or patient regarding a Smith & Nephew product (e.g. in terms of quality, durability, reliability, safety or performance) to the complaints department

Complies with all health, safety and environmental policies, procedures and job hazard analyses applicable to specified job activities; including medical evaluations as required by job function

Completes all required HSE training

Physical Demands:

•           Weight Lifting:  Mostly light (0kg - 5kg)   

•           Position: Mostly sitting

•           Repetitive Motion: Mostly computer use

•           Chemical Exposure:  No chemicals exposure or cleaning use only  

•           Physical Risk (Personal Protective Equipment – PPE):  No PPE required

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.','Regulatory','US-Pennsylvania-Pittsburgh','','Smith & Nephew','Full-time','Regulatory Affairs Specialist I (510K Submissions)-Medical Device

Company info

Smith & Nephew.
Website : http://www.smith-nephew.com

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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