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Regulatory and Security Specialist

Job SummaryReports to the Director of Regulatory Affairs or designate. Will assist the management of the global regulatory aspects of new product development and supply chain distribution for designated products with minimal direction from management. This position will prepare and submit documents necessary to gain US and foreign regulatory approval / clearance to place new or modified products into worldwide commercial distribution. The candidate will stay continually aware of new product development activities through ongoing communication with Marketing and Research & Development departments.
ESSENTIAL DUTIES AND RESPONSIBILITIES include the following. Other duties may be assigned.
Regulatory representative on new product development teams to ensure compliance with internal company requirements and compliance with regulatory requirements.
Provide expertise, make recommendations and give regulatory direction as an integral member of product development and supply chain teams.
Provide design change control and risk management process expertise to support the deployment and implementation of change control requirements. Provides direction to multi-disciplinary teams involved in product design changes to support compliance.
Review and approve engineering change orders, deviations, and corrective actions for product changes and/or modifications related to manufacturability and/or material modifications. Ensure compliance to existing regulatory submissions.
Provide on-going regulatory support for products and manufacturing /design facilities.
Ensure regulatory compliance to FDA and international regulations.
Excellent working knowledge of up-to-date domestic, international, and company regulatory compliance requirements and operating procedures.
Create and maintain regulatory submissions, Technical Files and Declarations of Conformity.
Effective facilitation skills to lead and motivate cross functional teams
Excellent verbal, written, and presentation communication skills.
QUALIFICATIONS
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
A minimum of a Bachelor's degree in science, biomedical engineering, medical/scientific writing, public health administration or a related area is required; An advanced degree in a technical, medical or business area is an asset; A minimum of 2 years of successful experience in a regulated healthcare environment (medical device, pharmaceutical, biologics) is required; Experience with domestic regulatory submissions is required; 510(k) and/or PMA submissions experience is required; Experience conducting regulatory activities in a clinical, regulatory, and/or quality or related area is required; Experience with international filing is an asset; Demonstrated understanding of Regulatory Affairs processes, both pre- and post-marketing is preferred; Excellent verbal and written communication skills required; Ability to work collaboratively in a team setting required.
LANGUAGE SKILLS
Ability to read and interpret documents such as safety rules, operating and maintenance instructions, and procedure manuals. Ability to write routine reports and correspondence. Ability to speak effectively before groups of customers or employees of organization.
MATHEMATICAL SKILLS
Ability to apply concepts such as fractions, percentages, ratios, and proportions to practical situations.
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.
CERTIFICATES, LICENSES, REGISTRATIONS
A minimum of a Bachelor's degree in science, biomedical engineering, medical/scientific writing, public health administration or a related area is required
PHYSICAL DEMANDS
The physical demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions. For safety, the use of contact lenses for any reason, cosmetic or corrective, is prohibited on the production floor, in the lab areas, in the engineering shop, or while working on equipment. The company will provide prescription safety glasses with a current (under 12 months) vision corrective prescription provided by the employee.
While performing the duties of this job, the employee is regularly required to sit and use hands to finger, handle, or feel; and talk and hear. The employee is occasionally required to walk and stand and reach with hands and arms. The employee must occasionally lift and/or move up to 50 pounds. Specific vision abilities required by this job include close vision, color vision, peripheral vision, depth perception, and ability to adjust focus.
MENTAL DEMANDS
The mental demands described here are representative of those that must be met by an employee to successfully perform the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions
While performing the duties of this position, the employee is regularly required to maintain a pleasant and professional manner with coworkers, customers and visitors. Must effectively handle and prioritize multiple tasks, concentrate on work while surrounded by distractions, meet deadlines, and work as a team player. The employee must be able to have the ability to make decisions on imperfect information and to communicate and give and receive complex oral and/or written instructions. Work with high level of efficiency. In addition, the employee must be able to determine and carry out appropriate actions addressing employee disciplinary issues.
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.
The employee must be able to work in a non-climate controlled manufacturing environment. The noise level in the work environment is usually moderate.
Please see attached job description. This is a new title with no profile assigned yet.
Must be a US Citizen.
DISCLAIMER:The above statements are intended to describe the general nature and level of work being performed by employees assigned to this classification. They are not intended to be construed as an exhaustive list of all responsibilities, duties and skills required of employees assigned to this position.Avantor is proud to be an equal opportunity employer.
EEO Statement
Avantor companies are equal opportunity employers, and all qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, gender identity, genetic information, national origin, protected veteran status, disability status, or any other characteristic protected by law.
This site is governed solely by applicable U.S. laws and governmental regulations. Use of this site constitutes your consent to application of such laws and regulations and our Privacy Policy.
Avantor? is a leading global provider of integrated, tailored solutions for the life sciences and advanced technology industries. Strengthened by the recent acquisition of VWR, the Company is a trusted partner to customers and suppliers from discovery to delivery. With operations in more than 30 countries and a diverse portfolio that includes more than four million products, Avantor enables customer success through innovation, cGMP manufacturing and comprehensive service offerings. Collectively, we set science in motion to create a better world.
Learn more at www.avantorinc.com and www.settingscienceinmotion.com.

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