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Sr Regulatory Affairs Specialist

  • Anywhere

Company :
Haemonetics Corporation

Location :
Boston, Massachusetts

Expiry Date :
Mon, 07 Dec 2020 23:59:59 GMT

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Description :
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 JOB SUMMARY Responsible for directing activities to ensure compliance with local regulations within US and Canada. Will initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services, with primary focus on in vitro diagnostics. Provides regulatory authorities with appropriate documentation in the aim of obtaining marketing authorization. Establishes and maintains relationships with external partners, and regulators. Responsible for following regulatory activities at local level. ESSENTIAL DUTIES Duties are listed in order of greatest importance. The incumbent may be asked to perform other function-related activities in addition to the below mentioned responsibilities as reasonably required by business needs. Enter Responsibilities/Essential Duties The Senior Regulatory Affairs Specialist responsibilities encompass working with regional RA, R&D, Quality, Marketing, Legal and any other relevant departments to compile technical information needed for supporting regulatory submissions for in vitro diagnostic (IVD) products. Key responsibilities include: Compile appropriate technical documents and author regulatory submissions with previous experience authoring and submitting US FDA 510(k) for IVDs and other medical devices. Review, assess and manage changes for on market products. Provide guidance to product development teams regarding specific local product submission requirements. Review proposed labeling changes to determine regulatory impact on existing certifications and registrations. Work with RA staff, clinical staff and program managers to develop regulatory approval strategies for products and project prioritization. Complete ad/promo review of marketing materials. Conduct training programs to educate employees on regulatory requirements and good regulatory practices. Review new regulatory guidance and participate in the implementation of programs to support compliance Communicate with customers to respond to regulatory concerns/questions. QUALIFICATIONS EDUCATION Education Level Education Details Required/Preferred Bachelor’s Degree preferred or equivalent work experience, preferably in a scientific or technical discipline EXPERIENCE Min. 5 years experience in a similar position Minimum 1 year Regulatory Affairs medical industry experience within medical devices LOCATIONPosition can be based in Boston, MA or fully remote in the United States. EEO Policy Statement