job summary: Randstad is looking for an Entry-level Regulatory Operations Specialist for a long-term opportunity in Bothell, WA
As a member of the Regulatory Operations team, the Regulatory Operations Specialist provides regulatory support for BG Ultrasound product lines and is responsible for building and delivering on competitive regulatory strategies. The Regulatory Operations Specialist works directly with regulatory agencies to achieve best possible outcomes for effective product market clearances. He / She is responsible for the coordination and preparation of document packages for regulatory submissions (FDA, Health Canada, EU Competent Authorities, CFDA, ANVISA, etc..) and to recommend strategies for clinical studies and evaluations.?
location: Bothell, Washington
job type: Contract
salary: $25 - 30 per hour
work hours: 8am to 5pm
responsibilities: Your responsibilities
- As the Regulatory Operations representative for BG Ultrasound and assists with regulatory issues related to such items as labeling and marketing ideas, prepares documents required in the Development Life Cycle, and recommends strategies for most efficient and effective approvals of regulatory applications for the business.
- Advise internal stakeholders (marketing, manufacturing, R&D, etc.) regarding current/pending guidance, regulations, agency/industry initiatives, etc. with an emphasis on global medical device labeling, to ensure regulatory strategy is in alignment with company objectives.
- Coordinate and prepare document packages for regulatory submissions to global regulatory agencies and/or competent authorities [510(k) Pre-market Notifications, PMAs, Product Reports/Supplements, US Device Listings, GUDID (UDI), Technical Files, Declarations of Conformity, Medical Device Licenses] for all manufacturing sites.
- Maintain existing regulatory filings/licenses, managing updates and related change control processes.
- Provides guidance on global compliance, such as CE Marking and product registrations, clinical evaluations in accordance with MDD Annex X & ISO 14155, Canada Medical Device Regulations, etc.
- Provide audit and CAPA support.
qualifications: Skills & Experience you bring to the role:
- Bachelor's degree in a technical / healthcare / business discipline or equivalent.
- 2 plus years of relevant experience in a medical device company (FDA Class I or II equivalent - Class III a plus).
- Experience in medical device regulations (21CFR), FDA law, MDD, other global laws and regulations and standards including ISO14971, IEC 60601, ISO14155, and other related particular standards.
- Excellent English skills (written and oral).
- Desired Qualifications:
- Certified regulatory affairs professional would be desirable.
- Experience with medical device labeling strongly preferred.
- Experienced in design control process.
Equal Opportunity Employer: Race, Color, Religion, Sex, Sexual Orientation, Gender Identity, National Origin, Age, Genetic Information, Disability, Protected Veteran Status, or any other legally protected group status.