Sr. Regulatory Affairs Specialist

Primary Talent Partners; Minnesota; Remote; USD 60,000 - 80,000; Full time

Job summary

A leading company in the medical device sector is seeking a Sr. Regulatory Affairs Specialist for a remote 10-month contract role. The ideal candidate will have a strong background in change control for Class II medical devices and excellent communication skills. This position involves regulatory assessments for USA and EU, and coordination of regulatory submissions, requiring a university degree and relevant experience.

Qualifications

• Requires a University Degree and a minimum of 4 years relevant experience.
• Advanced degree with a minimum of 2 years relevant experience acceptable.

Responsibilities

• Reviewing design, labeling, supplier and manufacturing changes for Class II medical devices.
• Leading coordination and preparation for regulatory submissions.

Skills

Communication

Change Control

Education

University Degree

Advanced Degree

Job description

2 days ago Be among the first 25 applicants

Primary Talent Partners provided pay range

This range is provided by Primary Talent Partners. Your actual pay will be based on your skills and experience — talk with your recruiter to learn more.

Base pay range

$50.00/hr - $60.00/hr

Primary Talent Partners has a 10 month contract opening for a Sr. Regulatory Affairs Specialist to join a multinational medical device company for a fully remote contract opening operating out of Mounds View, MN.

Pay: $50.00/hr - $60.00/hr based on experience and academia
Contract: 10 months, extensions likely, conversion possible
Type: W-2, cannot support C2C or sponsor visas
Hours: Full Time, 40 hours per week
Remote: 100% Remote

Top 3 Tasks / Responsibilities in scope for this role:

Reviewing design, labeling, supplier and manufacturing changes for Class II medical devices

Representing Regulatory function in a cross functional team setting

Complete regulatory assessments for both USA and EU geographies and work with regulatory geo staff to ensure global assessments, as needed are completed

Additional Responsibilities:

• Directs or performs coordination and preparation of document packages for regulatory submissions from all areas of company, internal audits and inspections.
• Leads or compiles all materials required in submissions, license renewal and annual registrations.
• Recommends changes for labeling, manufacturing, marketing, and clinical protocol for regulatory compliance.
• Monitors and improves tracking / control systems.
• Keeps abreast of regulatory procedures and changes.
• May direct interaction with regulatory agencies on defined matters.
• Recommends strategies for earliest possible approvals of clinical trials applications.

Required Education:

• Requires a University Degree and minimum of 4 years of relevant experience, or advanced degree with a minimum of 2 years relevant experience.

Top 3 things the manager is looking for in a candidates experience:

Understands change control for Class II medical devices and has a 2-5 years’ experience reviewing changes and determining the Regulatory impact

Strong communicator and able to work cross functionally

Strong understanding of change control for products that are commercialized

Primary Talent Partners is an Equal Opportunity / Affirmative Action employer committed to diversity in the workplace. All qualified applicants will receive consideration for employment without regard to race, color, religion, sex, sexual orientation, age, national origin, disability, protected veteran status, gender identity, or any other factor protected by applicable federal, state, or local laws.

If you are a person with a disability needing assistance with the application or at any point in the hiring process, please contact us at [e-mail]

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Seniority level

• Seniority level

  Entry level

Employment type

• Employment type

  Contract

Job function

• Job function

  Legal

• Industries

  Medical Equipment Manufacturing

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