The Regulatory Compliance Specialist will work under supervision to play an active role in the Regulatory Affairs department to assist in meeting the corporate objectives.
The Regulatory Compliance Specialist shall report to the Head of Regulatory Affairs and must possess strong knowledge of regulatory standards and requirements for medical devices. This position is a key role which will involve interaction with product development teams. The Regulatory Compliance Specialist must have experience in developing submissions, researching regulations for domestic and international regions and product life cycle management of medical devices (or IVDs).
- The primary responsibility of this position is to ensure regulatory and quality compliance to applicable medical device regulations. These responsibilities include performing searches of regulatory databases and regulatory reporting.
- Play a key role in advancing the regulatory affairs departments goals while improving current processes within the department.
- Maintenance of documentation: DHF (Design History Files), DMR (Design Master Records), Technical Files, Design Dossiers, IDE, 510(k) submissions and all regulatory communications from regulatory agencies.
- Experience with MDD 93/42/EEC and the new EU Medical Device regulations: EU MDR 2017/745; assist with the transition to the new EU regulations (gap assessment).
- The individual will collaborate closely with Quality Assurance to support compliance oversight and assist with updating SOPs, DHFs, DHRs and other documents as necessary.
- Maintain current knowledge of the developments and changes to applicable laws, regulations, guidelines and industry standards (including electrical and software standards); obtain and distribute updated information.
- Interpret regulatory rules or rule changes and ensure that they are communicated through company procedures, training and communication with stakeholders.
- Identifying, researching and gathering relevant information from a variety of sources.
- Analyzing and evaluating data, procedures, interrelated processes and other information.
- Formulating summary of research to regulatory department and other internal teams.
- Prepares compliance auditing and monitoring reports in accordance with the Compliance Program. Provides training and education to staff regarding the integration of compliance regulatory standards with programs and operations.
- Assist with technical review of data or reports that will be incorporated into regulatory submissions to assure scientific accuracy, consistency, and clearness.
- Assist marketing department with review of product promotional materials, labeling, specification sheets, or test methods for compliance with applicable regulations and policies.
- Support project development teams on subjects such as pre-market/pre-inspection/pre-license regulatory requirements, export and labeling requirements, or other regulatory compliance issues.
- Compile and maintain regulatory documentation databases or systems.
- Supports ongoing monitoring of compliance key performance indicators.
- Keeps abreast of regulatory issues.
EDUCATION & EXPERIENCE:
- Bachelor’s degree in an engineering or scientific discipline, with a minimum of 1-3 years of experience in Regulatory Affairs, preferably in the medical device or IVD industry.
- Good knowledge of various regulations (21CFR820, ISO 13485, ISO 14971), directives, guidance’s, especially the MDD 93/42/EEC and the new EU Medical device regulations: EU MDR 2017/745.
- Ability to communicate effectively within the regulatory team and internal cross-functional departments.
- Demonstrate in-depth understanding of technical/scientific principles related to medical devices and related standards.
- Strong computer skills.
- Effective technical writing and verbal communication skills.
- Ability to work in a fast-paced environment with shifting changes in prioritization based on regulatory and business needs.
- Ability to work effectively independently and within a team.
HIGHLY DESIRABLE SKILLS:
- Experience with US and EU standards for software and electrical components.
- Good attention to detail is necessary.
- Experience with the development of Class II and Class III medical devices.
- Excellent research and analytical skills.
- Ability to manage multiple projects.
- Performance Orientation – Is driven by personal performance; achieves all objectives detailed in IRRAS Department goals and comfortable with quantifiable assessments.
- Impact Orientation – Performs to stated objectives and driven to make an impact on company goals and patients’ lives.
- Competitive – Dedicated to a competitive spirit that supports the IRRAS goal to be the premier Medical Device company in the industry.
- Sense of Urgency – Has the speed and agility dedicated to the company’s goals and performance.
- Ability to Handle Pressure and Ambiguity – Comfortable with the pressure to be the best and the ability maintain composure and focus in situations of ambiguity and uncertainty.
- Confidence – Confident in one’s skills and abilities; pursues everything with energy; demonstrates the drive and a need to finish especially in the face of resistance or setbacks.
- Multitasking – Capable of performing multiple tasks over a certain period of time by executing them concurrently.
- While performing the duties of this job, the employee is regularly required to talk or hear.
- The employee is frequently required to sit.
- The employee is occasionally required to stand; walk; use hands to finger, handle, or feel and reach with hands and arms. Transition from standing and sitting often.
- Required specific vision abilities might include close vision, distance vision, color vision, peripheral vision, depth perception and ability to adjust focus.
- The employee might occasionally lift and/or move up to 10 pounds.
- General office environment.
- Daily exposure to PCs and networks.
- Exposure to normal office equipment: printer, fax, phones.
- The noise level in the work environment is usually moderate.
The physical demands and work environment characteristics described above representative those an employee may encounter while performing the essential functions of this job. Reasonable accommodations may be made to enable individuals with disabilities to perform the essential functions.
The above statements are intended to describe the general nature and level of work 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 personnel so classified.
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