Regulatory Affairs Specialist

3 weeks ago

Newark, United States Hologic Full time

Hologic is seeking a **Regulatory Affairs Specialist** to join our expanding Innovation Center located in Newark, DE.

**What to Expect**:
The **Regulatory Affairs Specialist **is expected to perform the coordination and preparation of document packages for regulatory submissions for new and mature products to ensure alignment and compliance with local and regional registration requirements as well as with company policies from all areas of company as well as internal audits and inspections. We expect the **Regulatory Affairs Specialist** to make recommendation changes for labeling, manufacturing, marketing and clinical protocol for regulatory compliance.

**What To Expect**:

- Prepares and compiles document packages for regulatory submissions, audits and inspections. Maintain regulatory databases and technical files.
- Reviews materials such as labeling, marketing materials or user manuals to ensure compliance with regulatory agency requirements and laws.
- Supports labeling and unique device identification requirements. Recommends changes for labeling, manufacturing, marketing and clinical protocols for regulatory compliance.
- Supports projects and cross functional teams. Participates in design reviews and regulatory strategies for product approvals.
- Participate in developing or improving processes, procedures and standards that contribute to meeting internal SOP’s, regulatory and industry regulations.
- Maintains current knowledge of existing and emerging regulations, standards and laws.

**Education**
- Preferred Minimum Non-Technical Degree: College Degree
- Preferred Minimum Technical/Advanced Degree: Technical Bachelor’s Degree

**Experience**
- Preferred Minimum Non-Technical Degree: 2-5 Years
- Preferred Minimum Technical/Advanced Degree: 1-2 Years with Technical Bachelor’s Degree, 0-2 Years with Master’s Degree
- Experience working in regulated medical device industry.

**Skills**
- Strong communication, including written, verbal, and interpersonal skills.
- Knowledge of document storage and ability to create technical files.
- Understanding of ISO 13485, ISO 9001, FDA and foreign regulatory requirements
- Data and statistical analysis skills
- High degree of attention to detail
- Regulatory Affairs Certification (RAC) is beneficial.
- Project Management Experience is beneficial.

So why join Hologic?

We are committed to making Hologic the company where top talent comes to grow. For you to succeed, we want to enable you with the tools and knowledge required and so we provide comprehensive training when you join as well as continued development and training throughout your career. We offer a competitive salary and annual bonus scheme, one of our talent partners can discuss this in more detail with you.

The annualized base salary range for this role is $70,000 - $109,500 and is bonus eligible. Final compensation packages will ultimately depend on factors including relevant experience, skillset, knowledge, geography, education, business needs and market demand.

Hologic, Inc. is proud to be an Equal Opportunity Employer inclusive of disability and veterans.

LI-#DS1

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