The Regulatory Affairs Specialist will work under supervision to play an active role in the Regulatory Affairs department to assist in meeting the corporate objectives. The position will report to the Head of Regulatory Affairs and possess strong knowledge of regulatory affairs strategy and submission requirements. This position is a key role which will involve interaction with product development and marketing teams. The Regulatory Affairs Specialist I must have experience in developing submissions, researching regulations for domestic and international regions and a strong background in product life cycle management of medical devices (or IVDs).
- Play a key role in advancing the regulatory affairs departments goals while improving current processes within the department.
- Assist with the preparation and review of regulatory submissions to obtain and maintain global regulatory approvals of products, including but not limited to: FDA (510k Submissions), EU Technical Documentation Files, ROW submissions, etc.
- Works on projects with medical devices consisting of disposables, hardware and software, which require broad analytical tools and techniques for analysis. Review validation, engineering and clinical protocols and reports (including SOPs, manufacturing process documents, specifications, results data) which may be included or summarized in regulatory submissions.
- Assist with regulatory strategy planning and change management in domestic and international markets, such as Asia Pacific, Latin America, the European Union, and MENA (Middle East North Africa.).
- Manage regulatory information relating to all regions and specific in-country regulations; maintain international regulatory files; reviewing and/or researching country-specific requirements for registration purposes.
- Support development teams working towards modifying existing devices or creating new products; ensure compliance with design controls, risk management, and domestic and international regulations.
- Collaborate with Engineering, R&D Development, Marketing, Clinical and other departments to ensure regulatory requirements are met in the markets where devices are distributed.
- Support Regulatory department with government queries and registration documentation. requirements; annual establishment registrations, ISO 13485 certification renewal.
- Assist with the maintenance of DHF, DHR and MDR files, Technical Files, 510(k) submissions and all regulatory licensing agreements.
- Assist Quality Assurance department with Regulatory review and approval of quality records such as those associated with Change controls, Non-Conforming Material Reports (NCMR), Deviations, and Corrective and Preventative Actions.
- Review Change Orders and assess regulatory impact of product changes on domestic and International regulatory strategy and submissions per standard procedures.
- Facilitate audits and inspections by regulatory agencies; collaborate with Quality Assurance to assist in audit preparation and execution
- Review labeling, training, promotional and advertising material for compliance to regulations.
- Support post market regulatory compliance activities for domestic and International product approvals.
- Develop and maintain regulatory affairs department procedures; must be fluent in writing SOPs and creating tracking spreadsheets, maintaining updates to all regulatory information.
- Review/approve documentation in support of design history file and risk management file (e.g. design inputs/outputs, hazard analysis, clinical evaluation reports); familiarity with usability and human factors.
- Ensure continued compliance with ISO 13485 and global regulatory requirements from FDA, EU and other applicable regions.
- Interface with Quality Assurance and Customer Facing Teams for product investigations for complaint issues.
- May perform additional duties as assigned or directed by management from time to time
- Bachelor’s degree in an engineering or scientific discipline; minimum of 5 years of experience in Regulatory Affairs, preferably in the medical device industry. Master’s degree a plus.
- Must be familiar with all aspects of regulatory strategy creation, design control, quality and product lifecycle requirements.
- Must be familiar with technical/scientific principles related to medical devices; electrical and software requirements for medical devices.
- Must be familiar with the laws, regulations, standards and guidelines governing medical devices: the IDE, 510(k) for FDA, as well as, European regulations, Technical Files and Design Dossiers.
- Good regulatory submissions experience in the medical device industry.
- Experience with US and EU standards for software and electrical components.
- Working knowledge of other international regulatory requirements and experience with Quality Systems in the medical device industry are a plus.
- Good knowledge of product development process and design control.
- Strong computer skills. Excellent written and oral communication, technical writing and editing skills. 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.
- Ability to work both independently and within a team.
- Ability to multi-task and prioritize projects to align with department and organizational objectives.
- 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.
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.
- 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.
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.
- General office environment.
- Daily exposure to PCs and networks.
- The noise level in the work environment is usually moderate.
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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