Regulatory Affairs Coordinator

Posted 10 May 2023
Salary US$39 - US$42 per hour + Medical, Dental, Vision, 401k
Job type Temporary
DisciplineLife Science Recruitment
Contact NameRachael Jalbuena

Job description

Regulatory Affairs Coordinator
10+ month contract
Hybrid - Danvers, MA (This is a hybrid role. Onsite 3 days a week)
Hourly Pay: $39-42/hr

Orion Group is seeking for a Regulatory Affairs Coordinator to work with our premiere medical device manufacturing client in Danvers, MA.

The Regulatory Affairs Coordinator completes a variety of administrative tasks for Regulatory project support which may include but is not limited to document formatting, document generation, document storage co-ordination and shipping of regulatory submissions. This role will be managing multiple deliverables including project planning and creation of action plans, tracking of bowlers, escalation communication, stakeholder management and Daily Management. The RA Coordinator works cross-functionally on specific projects as they arise (for example with R&D and/or QA).

Required Skills/Experience:
* 1-3 years of Regulatory Affairs experience required.
* High School Diploma or equivalent required. Associate or Bachelor's Degree preferred in science or related.
* IVD Regulatory Affairs or Quality Assurance experience is very beneficial and highly desirable.

* Excellent MS Word and MS Excel skills, Strong, independent worker capable of operating in a fast-paced, constantly changing environment.
* A self-starter able to manage their own workload and prioritize tasks accordingly.
* Must be results oriented with excellent organizational and time management skills.
* Excellent attention to detail. Must possess strong interpersonal and communication skills.
* Travel expectations within this role are limited and flexible (10%)

Required Skills/Experience:
* 1-3 years of RA experience required.
* High School Diploma or equivalent required.
* Associate or Bachelor's Degree preferred in science or related.

Our role in supporting diversity and inclusion
As an international workforce business, we are committed to sourcing personnel that reflects the diversity and values of our client base but also that of Orion Group. We welcome the wide range of experiences and viewpoints that potential workers bring to our business and our clients, including those based on nationality, gender, culture, educational and professional backgrounds, race, ethnicity, sexual orientation, gender identity and expression, disability, and age differences, job classification and religion. In our inclusive workplace, regardless of your employment status as staff or contract, everyone is assured the right of equitable, fair and respectful treatment.