The final salary or hourly wage, as applicable, paid to each candidate/applicant for this position is ultimately dependent on a variety of factors, including, but not limited to, the candidate’s/applicant’s qualifications, skills, and level of experience as well as the geographical location of the position.

Applicants must be legally authorized to work in the United States. Sponsorship not available.

Our client is seeking a Regulatory Affairs Specialist in Raleigh, NC

Role Description

• Regulatory strategy: Support strategy development for US FDA class III medical devices and combination products in the post-market lifecycle.
• Regulatory assessments: Review product and process changes and conduct regulatory assessments, ensuring the appropriate regulatory strategies are communicated to internal stakeholders. Conduct risk assessments and provide recommendations to mitigate regulatory risks.
• Regulatory submissions: Prepare, review, and submit regulatory submissions, including PMA supplements and reports for class III medical devices.
• Regulatory compliance: Maintain documentation and databases in accordance with internal procedures and applicable regulations, standards, and guidelines (e.g. FDA, ISO, USP).
• Regulatory interface and communication: Respond to regulatory agencies and coordinate responses with subject matter experts. Ensure internal stakeholders are apprised of inquiries from health authorities during the submission approval process according to departmental communication cascades.
• Cross-functional collaboration: Collaborate with cross-functional teams (e.g., Quality, Operations, Marketing, Supply Chain) to ensure regulatory requirements are met in throughout the product lifecycle.
• Document management: Maintain regulatory documentation and databases in accordance with company policies and procedures and department practices.

Skills & Requirements

• University degree; scientific discipline preferred, or the required years of direct experience.
• 4+ years’ experience in medical device industry
• 2+ years’ direct experience in medical device regulatory affairs, preferably with FDA class III devices.
• Knowledge of Quality Management System standards, including ISO 13485 and ISO 9001.
• Proficiency in MS Office (Excel, PowerPoint and Word)
• Prior experience with PMA Class III devices
• Strong communication skills
• Ability to quickly adapt to changes in fast-paced
• Attention to Detail
• Analytical Skills
• Time Management
• Digital Acumen
• Problem Solving
• Emotional Intelligence
• Resiliency
• Communication Leadership
• Collaboration
• Project Management
• Motivate & Influence
• Leadership
• Collaboration
• Project Management
• Motivate & Influence
• Knowledge of medical device regulations and governing laws such as 21 CFR 814, 21 CFR 814, 21 CFR 820.
• Strong analytical, investigative, and organizational skills. Demonstrate curiosity preferred.
• Ability to work under pressure, prioritize, and handle multiple tasks.
• Self-starter with results-oriented mindset.
• Excellent written and verbal communications
• This position requires you to sit, stand and perform general office functions. You may also be required to lift up to twenty-five pounds occasionally. Bending, stooping and reaching are also frequently required.

Benefits/Other Compensation

This position is a contract/temporary role where Hays offers you the opportunity to enroll in full medical benefits, dental benefits, vision benefits, 401K and Life Insurance ($20,000 benefit).

Why Hays?

You will be working with a professional recruiter who has intimate knowledge of the industry and market trends. Your Hays recruiter will lead you through a thorough screening process in order to understand your skills, experience, needs, and drivers. You will also get support on resume writing, interview tips, and career planning, so when there’s a position you really want, you’re fully prepared to get it.

Nervous about an upcoming interview? Unsure how to write a new resume?

Visit the Hays Career Advice section to learn top tips to help you stand out from the crowd when job hunting.

Hays is committed to building a thriving culture of diversity that embraces people with different backgrounds, perspectives, and experiences. We believe that the more inclusive we are, the better we serve our candidates, clients, and employees. We are an equal employment opportunity employer, and we comply with all applicable laws prohibiting discrimination based on race, color, creed, sex (including pregnancy, sexual orientation, or gender identity), age, national origin or ancestry, physical or mental disability, veteran status, marital status, genetic information, HIV-positive status, as well as any other characteristic protected by federal, state, or local law. One of Hays’ guiding principles is ‘do the right thing’.
We also believe that actions speak louder than words.
In that regard, we train our staff on ensuring inclusivity throughout the entire recruitment process and counsel our clients on these principles. If you have any questions about Hays or any of our processes, please contact us.

In accordance with applicable federal, state, and local law protecting qualified individuals with known disabilities, Hays will attempt to reasonably accommodate those individuals unless doing so would create an undue hardship on the company. Any qualified applicant or consultant with a disability who requires an accommodation in order to perform the essential functions of the job should call or text 813.336.5570.

Drug testing may be required; please contact a recruiter for more information.

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