ASQ 0502 JobSeekers

Position has been filled, thank you. 

Are you ready to be part of a dynamic company leading innovation in human performance technology? Due to continuing growth, BTE has a junior-level Quality/Regulatory Affairs Associate position available in the Quality department. With offices in the US and Canada, and a worldwide distributor base, BTE has been at the forefront of technology-assisted rehabilitation and physical abilities testing for over 30 years. Join our passionate, diverse group of talented professionals as we continue to reach new markets with industry leading healthcare products and services.

POSITION DESCRIPTION (PARTIAL LIST OF RESPONSIBILITIES)

The Quality/Regulatory Affairs Associate position will perform regulatory affairs duties such as completing and filing applications for medical device submissions and support of the Quality Assurance program within a medical device manufacturing facility.

The ideal candidate for the QA/RA Associate position will be experienced in handling a wide range of Quality Assurance and Regulatory Affairs-related tasks and will be able to work independently with minimal supervision. The candidate must be energetic, well-organized, flexible, and enjoy the administrative challenges of supporting an engineering and manufacturing facility.

A minimum of 2 years in a related technical field with exposure to US and international regulatory compliance is essential for this role. Candidates without this requirement will not be considered.

1) Support regulatory submissions to ensure compliance with FDA and international regulations and guidelines at the guidance of the Regulatory Manager;

2) Assist Regulatory department with preparation of regulatory documents including but not limited to annual reports, safety reports, annual filings, FDA communications, etc.;

3) Interact with all departments to co-ordinate preparation of and obtain necessary information for regulatory submissions and quality assurance activities;

4) Maintain and update regulatory and quality files and databases (both electronic and paper copy);

5) Provide QC review of data and reports that will be incorporated into regulatory submissions to ensure accuracy and clarity of presentation;

6) Support activities of the Quality Assurance and Regulatory departments as needed;

7) Write or update Standard Operating Procedures (SOPs) and working guidelines, as needed;

8) Provide support to production, clinical and engineering departments as needed;

Qualifications and Desired Skills

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1) University degree is required (preference will be given to those with degree in relevant field, though all candidates are welcome and encouraged to apply);

2) Appropriate full-time work or intern experience is mandatory (no students or new graduates please);

3) Recent experience in the medical device industry is strongly preferred;

4) Experience with ISO 9001, ISO 13485, IEC 60601, ISO 14971, IEC 62366, international medical regulations and requirements helpful;

5) Preference will be given to people who have recent experience in regulatory affairs;

6) Appropriate Regulatory or Quality certifications desirable;

7) Must possess excellent communication skills, both written and verbal, in order to present responses, prepare reports, and maintain communication with internal and external clients;

BTE’s expertise is human physical performance evaluation and treatment. Our Rehabilitation Equipment provides advanced evidence-based physical therapy systems for clinics, hospitals, and private practices. BTE’s Workforce Solutions provides employers with superior processes and technology to enable employers to optimize productivity, through lower absenteeism/turnover, improved safety, reduced injuries and claims costs, and measurably increased performance. With BTE, people and companies achieve better outcomes.

Founded in 1979, BTE’s mission is providing the highest quality, innovative solutions in physical evaluation and rehabilitation, meeting and exceeding our customers’ needs. BTE cares about making a difference in people’s lives through facilitating better clinical outcomes and safer workplaces. We employ a diverse team of individuals dedicated to our mission, offering excellent salary and benefit packages, including health, dental and vision insurance, and 401K. If you are a driven individual, excited about contributing your talents to an organization that cares, apply for our Quality/Regulatory Affairs Associate position today. Email your resume to jobs@btetech.com[\e2i].

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