Regulatory Affairs Specialist

Job Description

Job Description

Adecco Staffing is working with a leading medical device manufacturer in Bedford, MA to bring on a Regulatory Affairs Specialist. This is an excellent opportunity to join a global organization supporting worldwide regulatory compliance, product registrations, and post-market regulatory activities within a highly regulated industry.

Shift : Monday – Friday, First Shift 8am-5pm
Pay: $45/hr DOE
Location : Bedford, MA

Job Duties:
· Support worldwide product registrations, renewals, and regulatory compliance activities for medical device products
· Prepare correction and removal files, field communications, and regulatory strategies for management review and submission
· Author FDA Medical Device Reports (MDRs) and Health Canada Mandatory Problem Reports (MPRs)
· Support worldwide vigilance reporting activities and maintain regulatory records in compliance with applicable regulations
· Participate on design and risk management teams as the Regulatory Affairs representative
· Assist with preparation and maintenance of Technical Files, CE Mark documentation, 510(k) submissions, and Canadian license applications
· Support international product registrations and product renewal activities
· Review technical data and reports for inclusion in regulatory submissions
· Maintain regulatory databases and documentation within SAP
· Review labeling, change orders, and marketing materials to ensure regulatory compliance
· Collaborate with cross-functional teams including Quality, Engineering, Marketing, and Manufacturing
· Support additional Regulatory Affairs and Quality Assurance initiatives as needed

Requirements:
· Bachelor’s degree required, preferably in Life Sciences, Engineering, or a related field
· Experience in Regulatory Affairs, Quality Assurance, Medical Devices, or another highly regulated industry preferred
· Familiarity with ISO 13485 and ISO 14971 preferred
· Strong technical writing, documentation, and organizational skills
· Proficiency with Microsoft Office applications including Word, Excel, PowerPoint, and Adobe Acrobat
· Experience with SAP is a plus
· Ability to manage multiple projects and priorities in a fast-paced environment
· Strong communication and collaboration skills
· International regulatory support experience is a plus

Benefits:
· Weekly pay
· Opportunity to work with a global leader in the medical device industry
· Exposure to international regulatory submissions and compliance activities
· Professional growth and development opportunities
· Collaborative and innovative work environment

If you are interested in this position, please apply using the link provided and be sure to include an updated resume.

 

Pay Details: $40.00 to $45.00 per hour

Benefit offerings available for our associates include medical, dental, vision, life insurance, short-term disability, additional voluntary benefits, EAP program, commuter benefits and a 401K plan. Our benefit offerings provide employees the flexibility to choose the type of coverage that meets their individual needs. In addition, our associates may be eligible for paid leave including Paid Sick Leave or any other paid leave required by Federal, State, or local law, as well as Holiday pay where applicable.

Equal Opportunity Employer/Veterans/Disabled

Military connected talent encouraged to apply

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The Company will consider qualified applicants with arrest and conviction records in accordance with federal, state, and local laws and/or security clearance requirements, including, as applicable:

• The California Fair Chance Act
• Los Angeles City Fair Chance Ordinance
• Los Angeles County Fair Chance Ordinance for Employers
• San Francisco Fair Chance Ordinance

Massachusetts Candidates Only: It is unlawful in Massachusetts to require or administer a lie detector test as a condition of employment or continued employment. An employer who violates this law shall be subject to criminal penalties and civil liability.