Regulatory Affairs Specialist
5 days ago
We are seeking a highly skilled Regulatory Affairs Specialist to join our team at Lifelancer. This role will be responsible for supporting US and OUS regulatory affairs activities for Class II and III products.
Responsibilities- Participate in product development teams to provide regulatory support
- Compile technical documentation to support global regulatory submissions and registrations
- Write submissions and develop responses to questions or deficiencies
- Review QMS and product changes for compliance to regulatory requirements
- Create and/or update company SOPs, protocols/reports, labeling, etc.
- Maintain regulatory logs and registrations
- Provide input to regulatory department metrics and planning
- Provide regulatory review for advertising and promotional materials
- Conduct literature searches and other research in support of planned activities
- Familiarity with medical device requirements in the US and/or EU
- Knowledge of medical device regulations, standards, and guidance documents
- Bachelor's Degree required, preferably in STEM/Medicine/Life Science
- 1-2 years previous experience in medical device product development or related field
- High level of attention to detail and accuracy
- Ability to work effectively on cross-functional teams
- Strong communication, presentation, and interpersonal skills
- Basic understanding of data analysis
The estimated salary range for this role is $64,906-$87,707 per annum. In addition to compensation, Lifelancer offers a competitive suite of benefits to its employees, including 401(k), employee stock purchase plan, flexible time off, paid sick time, parental leave, short- and long-term disability insurance, tuition reimbursement, and health and welfare benefits.
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