Regulatory Affairs Specialist

We are constantly looking to add to our core talent. If you are seeking a career that is challenging and rewarding, a work environment that is diverse and dynamic, look no further - Haemonetics is your employer of choice. Job Details The Regulatory Affairs Specialist will be responsible for supporting US and OUS regulatory affairs activities for Class II and III products. Regulatory responsibilities include supporting regulatory submissions and operations, reviewing QMS and product documentation, and working with cross-functional team members to meet company milestones. Regulatory Affairs Responsibilities: Participate as a member of product development teams to provide regulatory support Proactively work with cross-functional team members to compile technical documentation to support global regulatory submissions and registrations Write submissions and develop responses to questions or deficiencies (e.g., US FDA, EU MDR, etc.) 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 (e.g., compliance with EU MDR) Participate in data analysis, interpretation, and synthesis to develop clinical study reports, clinical evaluation deliverables, and/or support development of scientific publications including peer-reviewed manuscripts. Required to work closely with data management and biostatistics to extract data in support of clinical affairs deliverables. Qualifications: Familiarity with medical device requirements in the US and/or EU (Class II and III experience is a plus) Knowledge of medical device US and EU regulations, standards, and guidance documents (21 CFR 820, MDR, ISO 13585, ISO 14971, etc.) Bachelor's Degree required, preferably in STEM/Medicine/Life Science. 1-2 years previous experience in medical device product development or related field. Regulatory affairs, clinical affairs, Quality, or Engineering experience required. (Internship or Coop experience may be considered as experience) Skills: Must have high level of attention to detail and accuracy. Must be able to work effectively on cross-functional teams. Must be able to manage or support multiple projects. Must have clear, logical writing ability. Strong communication, presentation, and interpersonal skills. Basic understanding of data analysis (e.g., descriptive statistics, statistical methods). Ability to learn quickly and self-educate on standards and regulations as applicable (self-starter attitude). Consistently shows dedication and strong work-ethic to help meet aggressive timelines or multiple projects when necessary. Proficiency in Word, Adobe Acrobat, and Excel. EEO Policy Statement Pay Transparency: The base pay actually offered to the successful candidate will take into account, without limitation, the candidate's location, education, job-knowledge, skills, and experience in prior relevant roles. Incentives may also be provided as part of Haemonetics' employee compensation. For sales roles, employees will be eligible for sales incentive (i.e., commission) under the applicable plan terms. For non-sales roles, employees will be eligible for a discretionary annual bonus, the target amount of which varies based on the applicable role, to be governed by the applicable plan terms. Employees may also be eligible to participate in the Company's long-term incentive plan, with eligibility and target amount dependent on the role. In addition to compensation, the Company offers a competitive suite of benefits to its employees, including without limitation, a 401(k) with up to a 6% employer match and no vesting period, an employee stock purchase plan, "flexible time off" for salaried employees and, for hourly employees, accrual of three to five weeks' vacation annually (based on tenure), accrual of up to 64 hours (annually) of paid sick time, paid and/or floating holidays, parental leave, short- and long-term disability insurance, tuition reimbursement, and/or health and welfare benefits. Depending on your location, you may be eligible for more detailed information related to the compensation and benefits related to this job posting. If you believe you may be entitled to such information by law, you may contact , Monday through Friday, 7:30 a.m. - 5 p.m. ET or email . The base salary range for this role is: $64,906.00-$87,707.00/Annual

Created: 2024-11-05