Change Control Specialist

Changing lives. Building Careers.

Joining us is a chance for you to do important work that creates change and shapes the future of healthcare. Thinking differently is what we do best. To us, change equals opportunity. Every day, more than 4,000 of us are challenging what's possible and making headway to help improve outcomes.

SUMMARY DESCRIPTION

This role will provide Change Control support for projects and daily operations. This role will act as a coordinator to ensure change controls meet the requirements of local and global SOPs. They will prioritize and track status of project specific changes. They may lead meetings focused on change control documentation. Will progress change controls including ECRs and DCRs in the Agile system. They will perform all duties in accordance with the requirements of overall corporate policies, FDA regulations, ISO 9001, ISO 13485, the medical device directive, and the other applicable regulatory agencies.

ESSENTIAL DUTIES AND RESPONSIBILITIES

To perform this job successfully, an individual must be able to perform each essential duty satisfactorily.

• Lead change control review board meetings to ensure changes are reviewed cross functionally

• Provide change control support to various departments as needed, e.g. engineering, product development, etc.)

• Acts as an initial change reviewer for compliance to the local and global SOPs.

• Tracks, follows-up and assists in the timely progression and closure of change controls including ECRs and DCRs.

• Provides hands-on guidance and training to change owners

• May also perform other related duties, responsibilities, and special projects as assigned.

DESIRED MINIMUM QUALIFICATIONS

The requirements listed below are representative of the knowledge, skill, and/or ability required for this position.

• B.S. degree in life science or engineering and minimum 3 years in progressive experience in Medical Device or Pharma.

• Extensive knowledge of appropriate global medical device regulations, requirements, and standards such as 21 CFR Parts 803, 806, 820, ISO 13485, ISO 14971 and Medical Device Directive, EUMDR.

• Excellent written and verbal communication skills.

• Strong organizational skills, self-directed, strong problem solving and interpersonal skills.

• Must be able to work independently with minimal supervision required.

• Expert MS office user a plus.

• Ability to work effectively in a cross functional environment

• Attention to detail, strong time management are essential

TOOLS AND EQUIPMENT USED

Computer skills to include MS Word, MS Excel, MS outlook, Ability to utilize a computer, telephone, copier, fax as well as other general office equipment proficiently. Able to train on measurement equipment use.

PHYSICAL REQUIREMENTS

The physical requirements listed in this section include, but are not limited, to the motor/physical abilities and skills require of this position in order to successfully undertake the essential duties and responsibilities of this position. In accordance with the Americans with Disabilities Act (ADA), reasonable accommodations may be made to empower individuals with disabilities to undertake the essential duties and responsibilities of the position.

While undertaking the essential duties and responsibilities of the position, the employee must repeatedly

sit, listen, speak, and write in English. The employee is required to go to all areas of the company. The employee may be required to periodically lift and/or move up to 25lbs.

ADVERSE WORKING CONDITIONS

The adverse working conditions listed in this section include, but are not limited to, those environmental conditions to which the employee may be exposed while undertaking the essential duties and responsibilities of this position, which is that of a general plant environment.

Adverse exposure may result from the handling of hazardous and biohazardous materials that include, but are not limited to, flammable and corrosive liquids, compressed gases, sharps, and medical wastes.

Integra LifeSciences is an equal opportunity employer, and is committed to providing equal employment opportunities to all qualified applicants and employees regardless of race, marital status, color, religion, sex, age, national origin, sexual orientation, physical or mental disability, or protected veteran status.

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