Regulatory Affairs Specialist (REMOTE)

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.

The Regulatory Affairs Specialist is responsible for directing activities to ensure compliance with local regulations for software (medical device and non-medical device) within North America. In this role you will initiate, develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services. Additionally, you will provide regulatory authorities with appropriate documentation in the aim of obtaining clearance/approval/license/certification, establishes and maintains relationships with external partners, regulators and opinion formers.

What Will You Do:

As a Regulatory Affairs representative for Haemonetics standalone software products you will work with product development teams to ensure all regulatory requirements are met prior to product release; Provide standalone software regulatory support throughout the software development lifecycle.

Activities may include:

• evaluating change requests to determine regulatory impact in North America,

• developing regulatory approval strategies,

• ensuring Unique Device Identification (UDI) compliance,

• participating in development meetings to provide regulatory guidance,

• reviewing/approving required design deliverables and labeling, and

• working with cross-functional team members to compile technical documentation to support regulatory submissions.

• You will support Regulatory Team Members outside of North America to obtain medical device certification/approval for their local jurisdictions.

• Review marketing and education materials for regulatory compliance.

• Review new/updated regulatory guidance(s) and participate in the implementation of programs to support compliance.

• Review proposed labeling changes to determine regulatory impact on existing certifications and registrations and provide guidance to Labeling/Technical Writing team on regulatory requirements and expectations for customer-facing documentation.

• Familiar with Class II FDA 510(k)'s, EU MDR and Health Canada Medical Device Applications specifically for software preferred..

• Support Internal and External audits as required.

EDUCATION/EXPERIENCE:

• Bachelor's Degree required.

• 3 plus yrs experience in the medical device industry required.

• 3 plus yrs experience in a regulated environment working within CFR21 Part 820, ISO13485 and ISO14971 required.

• 1 year experience with regulated software under the Software Development Process (IEC 62304), the Agile Development Process (TIR45) and Cybersecurity (ISO 27001), required.

• Experience participating in Quality System (QS) audits.

• Demonstrated understanding of Health Canada Applications (Class I, II, III), EU MDR CE Tech Files (Class I, IIa, IIb), US FDA 510(k)s and is familiar with registration process across different regions for standalone software.

• Intermediary knowledge of Microsoft Suite tool, JIRA, Agile PLM

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 1-781-348-7777, Monday through Friday, 7:30 a.m. - 5 p.m. ET or email AskHR@Haemonetics.com.

The base salary range for this role is: