As a global leader in staffing and recruitment, we are dedicated to connecting you with opportunities that foster growth and advancement in the life sciences sector. Working with a recruiter gives you exclusive access to a vast network of top employers and valuable insights into a wide range of roles. One of our premier partnerships is with a world-renowned leader in eye care, committed to advancing vision health through innovative surgical and vision care solutions. With a strong legacy of groundbreaking developments, this company is making a meaningful impact on the lives of millions worldwide. If you're looking to contribute to cutting-edge advancements in eye care and be part of a team shaping the future of vision health, this could be the perfect opportunity for you!
As a Regulatory Affairs Specialist, you are responsible for unleashing the full potential of our people and culture while simultaneously achieving timely and cost-effective manufacturing of high-quality medical devices. You are responsible for providing administrative support in ensuring compliance with all FDA and other U.S. and global regulatory requirements.
Position Type: Contract role for 2 years (through February 2027)
location: Fort Worth, Texas
job type: Contract
salary: $40.00 - 44.88 per hour
work hours: 9 to 5
education: Bachelors
responsibilities:
- Compile and maintain regulatory documentation databases or systems.
- Coordinate efforts associated with the preparation of regulatory documents or submissions for medical devices (US, EU and Canada submissions). Communicate with internal stakeholders 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. Conduct regulatory impact assessment for post approval changes and support preparation of necessary submission documentation
- 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 changes.
- 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.
- 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.
- Review clinical protocols to ensure collection of data needed for regulatory submissions.
- Write or update standard operating procedures, work instructions, or policies.
qualifications:
- Bachelor's degree (BS) in relevant field (Biology, Chemistry, Biomedical Engineering, Regulatory Affairs, or related discipline)
- One (1) to three (3) years of regulatory affairs submissions experience in a pharmaceutical, biotech, or medical device industry
- Experience with regulatory documentation, technical file maintenance, and submission support.
- Strong communication skills, written and verbal
- Medical Device experience
- Some exposure to FDA submissions (510k) or EU MDR, and/or Health Canada regulatory processes.
- Knowledge of ISO 13485 and/or ISO 14971
skills: GCP (Good Clinical Practice), Regulatory Affairs Operations, Regulatory Affairs Strategy, Regulatory Briefing Documents, Submissions
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.
At Randstad, we welcome people of all abilities and want to ensure that our hiring and interview process meets the needs of all applicants. If you require a reasonable accommodation to make your application or interview experience a great one, please contact HRsupport@randstadusa.com.
Pay offered to a successful candidate will be based on several factors including the candidate's education, work experience, work location, specific job duties, certifications, etc. In addition, Randstad offers a comprehensive benefits package, including health, an incentive and recognition program, and 401K contribution (all benefits are based on eligibility).
This posting is open for thirty (30) days.
