Regulatory Affairs Specialist
Fast growing ISO 9001 and 13485 certified manufacturer and global leader in the technical apparel world. This Private Equity held company, with an open and friendly/family like environment is seeking a Regulatory Affairs Specialist to be located in their facility NE of Atlanta. The position reports to the Director of QA/RA and includes a competitive salary, amazing benefits such as 401K (eligibility after 1 month of employment – with company matching), Group Medical/Dental/Vision, company paid life insurance, company paid ST and LT disability insurance, and unlimited PTO.
The Regulatory Affairs Specialist coordinates and documents internal regulatory processes, such as internal audits, inspections, license renewals, or registrations. May compile and prepare materials for submission to regulatory agencies.
Essential Duties and Responsibilities:
- Compile and maintain regulatory documentation databases or systems
- Coordinate efforts associated with the preparation of regulatory documents or submissions
- Analyze product complaints and make recommendations regarding their reportability
- Develop or conduct employee regulatory training
- Communicate with regulatory agencies regarding pre-submission strategies, potential regulatory pathways, compliance test requirements, or clarification and follow-up of submissions under review
- Coordinate, prepare, or review regulatory submissions for domestic or international projects
- Interpret regulatory rules or rule changes and ensure that they are communicated through corporate policies and procedures
- Provide technical review of data or reports that will be incorporated into regulatory submissions to assure scientific rigor, accuracy, and clarity of presentation
- Review product promotional materials, labeling, batch records, specification sheets, or test methods for compliance with applicable regulations and policies
- Advise project teams on subjects such as premarket regulatory requirements, export and labeling requirements, or clinical study compliance issues
- Determine the types of regulatory submissions or internal documentation that are required in situations such as proposed device changes or labeling change
- Identify relevant guidance documents, international standards, or consensus standards and provide interpretive assistance
- Maintain current knowledge base of existing and emerging regulations, standards, or guidance documents
- Obtain and distribute updated information regarding domestic or international laws, guidelines, or standards
- Participate in internal or external audits
- Prepare or direct the preparation of additional information or responses as requested by regulatory agencies
- Prepare or maintain technical files as necessary to obtain and sustain product approval
- Recommend changes to company procedures in response to changes in regulations or standards
- Prepare responses to customer requests for information, such as product data, written regulatory affairs statements, surveys, or questionnaires
- Write or update standard operating procedures, work instructions, or policies
- Coordinate recall or market withdrawal activities as necessary
- Develop or track quality metrics
- Review adverse events and file all related reports in accordance with regulatory agency guidelines
- Bachelor’s Degree in a related medical, science or business discipline
- 1-3 years in an ISO and FDA regulated environment (GMP, MDR, QSR, ISO 13485, ISO 9001)
- 2+ years of professional Quality experience
All Candidates must be able to provide work related references.
To apply for this job email your details to email@example.com
Rush & Company is a full service Executive Search Firm that specializes in the Soft Goods industry.
Included in this industry are the apparel, home furnishings and industrial markets. We work in the fiber, fabric and fashion industry with clients and candidates located all over the world.
All candidates must be able to provide work related references.
If you're a candidate and would like to submit your confidential resume, please use firstname.lastname@example.org. We will contact you if your qualifications match any of our current job searches.