Job Description

Regulatory Compliance Specialist

Type: 6+ Contract with potential for conversion to full time

Location: Plymouth, MN

Synergis’ client, a leading veterinary health company, has engaged us in a search for a Regulatory Compliance Specialist to augment their growing team to launch a new product! The Regulatory Compliance Specialist will play a key role in making sure that the products and company processes comply with the laws, standards, and regulations that govern these new products.

Regulatory Compliance Specialist | Background and Scope

• Draft, edit, and review regulatory agency submission materials to ensure timeliness, accuracy, comprehensiveness, and compliance with regulatory standards.
• Develop and enact regulatory compliance strategies for CMC submissions related to IVD medical devices / assay cartridges.
• Provide training in compliance practices and procedures.
• Review documentation, processes, and practices.
• Monitor compliance and facilitate interventions to manage risks.
• Perform compliance audits and compile reports.
• Communicate regulatory information to multiple departments and ensure that information is interpreted correctly.
• Provide regulatory guidance to departments and development project teams regarding design, development, and evaluation of products.
• Formulate and/or implement regulatory affairs policies and procedures to ensure that regulatory compliance is maintained or enhanced.
• Ensure compliance with global regulatory requirements and guidelines, including CE mark.

Regulatory Compliance Specialist | Requirements

• Bachelor’s Degree in a related field with 5-7 years of related experience; preferably in a Class I/II environment.
• Have successfully completed FDA 510k submissions for IVD medical devices (including devices that run assay cartridges).
• Working knowledge of ISO 13485 and FDA GMP (Good Manufacturing Practices).
• Solid knowledge of and experience working under MDD and MDR guidance.
• Strong written and verbal communication skills and proven ability to work effectively with cross-functional teams.
• Must be detail-oriented and have good organization and follow-up skills.
• Proven ability to meet deadlines, work under ambitious timelines, while being flexible and responsive to changing business demands

Business Analyst | Other:

• Onsite 5 days per week.
• Only candidates within commute distance to Plymouth, MN are being considered at this time.

About Our Client

Our client is a veterinary health organization dedicated to supporting clinical veterinarians with solutions that enhance both patient outcomes and practice success. Their team brings together experts in animal health, research, clinical care, and business, all united by a mission to help practitioners reconnect with the passion that drew them to veterinary medicine and rediscover fulfillment in their work.

The hourly pay rate range for this position is $48 to $52(dependent on factors including but not limited to client requirements, experience, statutory considerations, and location). Benefits available to full-time employees: medical, dental, vision, disability, life insurance, 401k and commuter benefits.

Synergis is proud to be an Equal Opportunity Employer. We value diversity and do not discriminate on the basis of race, color, ethnicity, national origin, religion, age, gender, gender identity, political affiliation, sexual orientation, marital status, disability, military/veteran status, or any other status protected by applicable law.

Qualified applicants with arrest or conviction records will be considered for employment in accordance with the requirements of applicable state and local laws, including but not limited to, the San Francisco Fair Chance Ordinance, the City of Los Angeles’ Fair Chance Initiative for Hiring Ordinance, the Los Angeles County Fair Chance Ordinance for Employers and the California Fair Chance Act.

For immediate consideration, please forward your resume to mgreen@synergishr.com

If you require assistance or an accommodation in the application or employment process, please contact us at mgreen@synergishr.com.

Synergis is a workforce solutions partner serving thousands of businesses and job seekers nationwide. Our digital world has accelerated the need for businesses to build IT ecosystems that enable growth and innovation along with enhancing the Total Experience (TX). Synergis partners with our clients at the intersection of talent and transformation to scale their balanced teams of tech, digital and creative professionals. Learn more about Synergis at

Job Tags

Similar Jobs