Regulatory Affairs Specialist

4 days ago

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Haemonetics

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Blood collection and separation technologies • surgical blood salvage systems • diagnostic products • software and information technology platforms • consulting services

1001 - 5000

Description

• Responsible for supporting US and OUS regulatory affairs activities for Class II and III products • Support regulatory submissions and operations, and review QMS and product documentation • Work with cross-functional team members to meet company milestones

Requirements

• 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 • Strong communication, presentation, and interpersonal skills. • Basic understanding of data analysis (e.g., descriptive statistics, statistical methods)

Benefits

• 401(k) with up to a 6% employer match and no vesting period • Employee stock purchase plan • Flexible time off for salaried employees • Accrual of three to five weeks’ vacation annually for hourly employees • Accrual of up to 64 hours of paid sick time annually • Paid and/or floating holidays • Parental leave • Short- and long-term disability insurance • Tuition reimbursement • Health and welfare benefits