Senior Regulatory Affairs Specialist

Surgical Specialties   •  

Braintree, MA

Industry: Business Services

  •  

8 - 10 years

Posted 424 days ago

This job is no longer available.

Company Overview:

At Surgical Specialties Corporation, we are motivated by enabling our customers’ success. That starts with understanding their needs and developing products that enhance clinical outcomes. Our goal is to provide innovative, high-quality products and service that will ensure the continued success of our company and the surgical professional well into the future.

Our precision manufacturing expertise along with our highly targeted sales and marketing capabilities help us offer novel and differentiated medical device products to patients and physicians, as well as to other medical device manufacturers and distributors.

Commitment to the Customer, Sense of Urgency, Focus, Accountability, and Teamwork define our culture and our organization and drive everything that we do.

We are seeking progressive, creative, customer oriented and highly skilled individuals for unparalleled opportunity.

Bring your passion, energetic vision, and entrepreneurial spirit to work for a company that will reward your commitment and encourage your potential. You can view current employment opportunities and apply online for a position with Surgical Specialties Corporation through our Online Career Center.

Overview:

Reporting to the Vice President of Quality / Regulatory Affairs, the Senior Regulatory Affairs Specialist is responsible for preparing regulatory submissions and registration documentation. They also provide quality and timely regulatory support to obtain marketing clearance / approval for new products; devices/drugs, drug-device combinations and maintain marketability of existing products.

Overall Responsibilities:

  • Assist in the implementation of company’s international regulatory submission strategy.
  • Compile required documents from source areas for submission.
  • Review critical documents to assure completeness, and with supervision, will prepare responses to routine in-country representative or regulatory agency results.
  • Ensure the content, organization and overall quality of all regulatory documentation are adequate and sufficient to comply with local, regional and / or international regulatory requirements, commitments and agreements.
  • Development of tracking documents and follow-up to assure submissions are managed appropriately.
  • Perform the coordination and preparation of document package for regulatory submissions (US and international).
  • Compile all materials required in submissions, license renewal and annual registrations.
  • Keep abreast of regulatory procedures and changes. May have direct interaction with regulatory agencies on defined matters.
  • Represent regulatory affairs on project teams.
  • Develop and recommend strategies for earliest possible approvals of device applications.
  • Generate departmental procedures.
  • Ensure documents are apostilled, certified and legalized or notarized, as required.
  • Assess new and / or modified standards, regulations and / or laws and determine applicability to the organization and / or product.
  • Complete other related duties as required.
  • Conduct oneself consistent with company standards at all times during work hours or when acting as a representative of the company.

Requirements

Education: Bachelor’s degreerequired in a technical discipline, such as Engineering, Bio-Medical Engineering, Computer Science, Biology or Chemistry. Masters Degreed preferred.

Experience: Minimum 8 – 10 years experience in Regulatory Affairs in the medical device/drug industry. Must have experience with regulatory registration and/or submissions in markets such as US, Canada, Japan, China, Korea, Taiwan and South America. Must have experience with Standards (ISO, IEC and EN).

02184