Senior Regulatory Affairs Specialist

Job not on LinkedIn

July 15

Apply Now

Receive Emails with Similar Jobs

Haemonetics

WebsiteLinkedInAll Job Openings

Healthcare Insurance • Pharmaceuticals

Haemonetics is a company that provides a suite of innovative medical technology solutions aimed at improving the quality, effectiveness, and efficiency of healthcare. The company focuses on optimizing operations for plasma centers, enhancing patient care in hospitals, and driving efficiency in blood centers by offering advanced technologies that improve productivity, quality, and safety. Haemonetics is committed to advancing healthcare standards and creating better outcomes for patients through their technology and services.

1001 - 5000 employees

Founded 1980

⚕️ Healthcare Insurance

💊 Pharmaceuticals

📋 Description

• Responsible for directing activities to ensure compliance with local regulations within North America (US and Canada) • Initiate, develop and implement all phases of regulatory strategy • Provides regulatory authorities with appropriate documentation • Establish and maintain relationships with external partners, regulators, and opinion formers • Compile technical documents and author local regulatory submissions for FDA and Health Canada • Provide guidance to product development teams regarding local product submission requirements • Review proposed labeling changes • Work with RA staff, clinical staff, and program managers to develop regulatory approval strategies • Conduct training programs on regulatory requirements • Communicate with customers to respond to regulatory concerns/questions • Maintain product registration database

🎯 Requirements

• Bachelors Degree required, preferably in STEM/Medicine/Life Science • Masters Degree in Regulatory Affairs preferred • 2+ years of Regulatory Affairs experience required

🏖️ Benefits

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