Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada)
Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada)
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Job 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
Responsible for directing activities related to our in-vitro diagnostic products to ensure compliance with local regulations within North America (US and Canada). Will initiate develop and implement all phases of regulatory strategy to ensure necessary approvals for company products/services. Provides regulatory authorities with appropriate documentation in the aim of obtaining licenses and regulations. Establishes and maintains relationships with external partners regulators and opinion formers. Responsible for following regulatory activities at local level.
The Senior Regulatory Affairs Specialist responsibilities encompass to work with corporate RA R&D Marketing Legal Business Leader and any other relevant department to compile technical information for supporting regulatory submissions for the countries of the region.
Key Responsibilities:
Compile appropriate technical documents and author local regulatory submissions for FDA and Health Canada.
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.
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.
Maintain product registration data base for North American countries.
May manage communication about vigilance issues for US and Canada.
May lead and direct the work of others.
Qualifications:
Bachelors Degree required preferably in STEM/Medicine/Life Science. Masters Degree in Regulatory Affairs preferred.
2 years of Regulatory Affairs experience with a focus on IVD industry REQUIRED
Pay Transparency:
The base pay actually offered to the successful candidate will take into account without limitation the candidates 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 Companys 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- Monday through Friday 7:30 a.m. 5 p.m. ET or email .
The base salary range for this role is:
$87892.99-$118774.78/AnnualRequired Experience:
Senior IC
Employment Type
Full-Time
