Senior Regulatory Specialist

, Permanent

Position: Senior Regulatory Specialist- Hybrid 3 days on-site and 2 days remote.

Company Overview:

Direct Recruit Agency is a leading recruitment agency that specializes in connecting top talent with companies in a variety of industries. We pride ourselves on our commitment to finding the best fit for both our clients and candidates. Our team is dedicated to providing exceptional service and building long-term relationships with our clients.

Job Summary:

We are seeking an experienced Senior Regulatory Specialist to join our team. The Senior Regulatory Specialist will be responsible for ensuring compliance with all relevant laws, regulations, and guidelines for our clients. The ideal candidate will have a strong understanding of regulatory requirements and experience in developing and implementing compliance programs.

Key Responsibilities:

- Conduct thorough research and analysis of regulatory requirements for various industries and clients

- Develop and implement compliance programs to ensure adherence to relevant laws, regulations, and guidelines

- Monitor changes in regulations and update compliance programs accordingly

- Provide guidance and support to clients on compliance matters

- Develop and maintain relationships with regulatory agencies

- Conduct internal audits and investigations to identify any potential compliance issues

- Train and educate employees on compliance policies and procedures

- Stay up-to-date on industry trends and best practices related to compliance

- Collaborate with cross-functional teams to ensure compliance in all aspects of the business

- Prepare and submit reports to regulatory agencies as required

- Must demonstrate the ability to provide regulatory support through the product life cycle on product project teams (e.g.,
developing regulatory strategies, change control assessments, timeline development, and reviewing submission-related documents).
- Familiarity with STED and/or technical file updates for CE marking activities and notified body interaction to maintain EU/MDR product registrations required
- Must be able to maintain confidentiality in dealing with regulatory and clinical documentation
- Must be able to prioritize and handle several projects concurrently.
- Must be self-motivated by working independently and having the ability to take ownership of their responsibilities.
- Must know the U.S. and European medical device regulations.
 -Must have technical writing skills and be proficient at compiling successful submissions for the appropriate audience

Qualifications:

- Bachelor's degree in a relevant field such as law, business, or public policy

- Minimum of 4 years of experience in regulatory compliance

- Strong understanding of relevant laws, regulations, and guidelines

- Experience developing and implementing compliance programs

- Excellent communication and interpersonal skills

- Ability to work independently and as part of a team

- Strong analytical and problem-solving skills

- Attention to detail and ability to multitask in a fast-paced environment

- Proficient in Microsoft Office and other relevant software

Preferred
Regulatory Affairs Certification (RAC) is preferred.
Author and support 510(k), Tech File / STED File submissions as required.
Provide regulatory support and guidance for post-market activities and labeling review.
Potential limited travel required 15%.

We Offer:

- Competitive salary and benefits package

- Opportunities for career growth and development

- A positive and collaborative work environment

- The chance to work with top clients in a variety of industries

If you are a highly motivated and experienced regulatory specialist looking for a new challenge, we would love to hear from you! Apply now to join our dynamic team at Direct Recruit Agency.