Senior Regulatory Affairs Specialist (Sustaining) — Medical Device (Hybrid — Marlborough, MA) Contract

Overview:

From development to commercialization, we partner with Pharmaceutical, Medical Device and Biotechnology clients to provide solutions to complex compliance issues. We collaborate with our partners by providing technical expertise in Quality, Regulatory Compliance and Manufacturing Science and Technology. Our business mission is to ensure our clients exceed their compliance goals while improving patient health and safety. Visit us at www.pharmavise.com and follow us on LinkedIn: https://www.linkedin.com/company/pharmavisecorp

Our Fortune 500 Medical Device client has an exciting opportunity for a Senior Regulatory Affairs Specialist (Sustaining).

Job Summary:

The Senior Regulatory Affairs Specialist (Sustaining) will provide regulatory support on a range of Endoscopy devices and activities which include evaluation of post market design changes, international submission support, commercial, manufacturing, & compliance support as well as other responsibilities aligned with global medical device regulations and goals of the business.

Responsibilities:

• MDR Sustaining support related to Periodic Safety Update Report (PSUR), Summary of Safety and Clinical Performance (SSCP), and/or Sampling Plan submissions. This is inclusive of the following activities:
• Leading Core Team meetings to collaborate cross-functionally on PSUR, SSCP, and Sampling Plan submissions
• Approving change notices for documentation updates required to submit to Notified Bodies
• Prepping and submitting documentation submission package to Notified Body
• Act as primary contact to Notified Body for any product submission questions
• Reviews and collaborates with design, clinical, and manufacturing teams on responses to questions from EU regulatory bodies related to compliance to the EU Medical Device Regulation
• Regulatory Sustaining product support. This is inclusive of the following activities:
• Active engagement in product / project team meetings
• Review, recommend appropriate changes, and approve product change notices
• Prepare and submit regulatory documentation and applications, as applicable
• Review device labeling and advertising materials for compliance with submissions and applicable regulations; analyze and recommend appropriate changes
• Review and approve product and manufacturing changes for compliance with regulatory requirements
• Design History File documentation creation, updates, and approval within the documentation management system
• Support and maintain Quality initiatives in accordance with Quality Policy
• Continuously assess ways to improve Quality

Basic Qualifications:

• Bachelor’s degree or equivalent work experience, preferably in a scientific or technical discipline
• 5 years Regulatory Affairs experience, medical device industry experience required
• Working knowledge of FDA and international regulations for medical devices
• General understanding of product development process and design control
• General understanding of regulations applicable to the conduct of clinical trials

Preferred Qualifications:

• Ability to manage several projects of moderate scope and complexity
• Proficiency with Microsoft Office
• Effective research, analytical, and problem-solving skills
• Effective written and oral communication, technical writing, and editing skills
• Ability to work independently with minimal supervision

Other Details:

• Schedule: 40 hours per week
• Contract Length: 6 months
• Work Setup: Hybrid in Marlborough, MA (3 days onsite, 2 days remote)

In addition to a dynamic and collaborative work environment, we offer a comprehensive benefits package to support our employees' well-being. Our benefits include paid holidays, Paid Time Off (PTO) policy, and medical insurance to ensure our team members have the flexibility and coverage they need. We believe in fostering a healthy work-life balance while providing the necessary support for professional and personal growth.

EEO Employer:

Pharmavise Consulting Corp. is an equal opportunity employer. We do not discriminate or allow discrimination on the basis of race, color, religion, creed, sex (including pregnancy, childbirth, breastfeeding, or related medical conditions), age, sexual orientation, gender identity, national origin, ancestry, citizenship, genetic information, registered domestic partner status, marital status, disability, status as a crime victim, protected veteran status, political affiliation, union membership, or any other characteristic protected by law. Pharmavise Consulting Corp. will consider qualified applicants with criminal histories in a manner consistent with the requirements of applicable law. If you have visited our website in search of information on employment opportunities or to apply for a position, and you require accommodation in using our website for a search or application, please contact info@pharmavise.com.

Pharmavise Consulting Corp. is a regulatory compliance consulting firm that partners with Pharmaceutical, Medical Device and Biotechnology clients. When you join Pharmavise, you become part of a team that values Excellence Through Quality.

E-Verify Participation:

Pharmavise Consulting Corporation participates in E-Verify and will provide the federal government with your Form I-9 information to confirm that you are authorized to work in the U.S. If E-Verify cannot confirm that you are authorized to work, Pharmavise is required to give you written instructions and an opportunity to contact the Department of Homeland Security (DHS) or Social Security Administration (SSA) so you can begin to resolve the issue. For more information on E-Verify, please contact DHS at 888-897-7781 or through their website at dhs.gov/e-verify.