Haemonetics Software Solutions
Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada)
Haemonetics Software Solutions, Boston, Massachusetts, us, 02298
Haemonetics is committed to the protection of personal data in accordance with applicable laws and regulations.
The editor and data controller ofwww.haemonetics.com is Haemonetics Corporation, 125 Summer Street, Boston, Massachusetts, 02110 U.S.A. The global Data Privacy Officer of Haemonetics can be reached at this address.
Senior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada) page is loadedSenior Regulatory Affairs Specialist (IVD Exp. supporting US/Health Canada)Apply locations Boston, MA, US US Remote time type Full time posted on Posted 6 Days Ago job requisition id R9668
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.
Have you got what it takes to succeed The following information should be read carefully by all candidates.
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
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: $87,892.99-$118,774.78/Annual #J-18808-Ljbffr
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.
Have you got what it takes to succeed The following information should be read carefully by all candidates.
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
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: $87,892.99-$118,774.78/Annual #J-18808-Ljbffr