Regulatory Affairs Spec in Andover

The Regulatory Affairs Specialist will work hybrid in our Andover, MA office. The Regulatory Affairs Specialist will develop the basic knowledge and understanding of the regulatory and legal frameworks, regulatory requirements, processes and procedures. This position will work with supervision to ensure continued market access and ongoing regulatory compliance of the Draeger Patient Monitoring device portfolio in US and international markets. This position will support the gathering of regulatory intelligence to assist in the development of local, regional, and global regulatory strategies, and will support the execution of post market product lifecycle management.

Develops regulatory strategies by:

• Determining requirements (local, national, international) and options for regulatory submission, approval pathways, and compliance activities.
• Assessment of options and milestones to de-risk development programs and align with current regulatory requirements and agency guidance.
• Documenting path(s) to regulatory approval in the Regulatory Affairs Plan (RAP).
• Developing clear rationales for Letter-to-File (LTF) for product changes that will not impact product approvals or clearances.

Responsible for:

• The procurement, assembly, and packaging of the required deliverables for the submission of product registration and approval information as appropriate.
• Preparation and submission of regulatory documentation according to applicable regulatory requirements and guidelines.
• Communication and interaction with regulatory authorities before and during the development and review of a regulatory submission through appropriate communication tools.
• Review labeling and marketing literatures for compliance with regulatory requirements.
• Providing product support in preparing US and non-US product submissions (510(k), Technical files, Canadian Licenses and International Registrations), by assessing the acceptability of quality, preclinical, and clinical documents in regulatory submissions to ensure compliance with applicable regulations.
• Providing support for domestic (federal, state, and local) and International products registrations, by researching existing documentation, preparing summary information, memos or statements (including CFG's; certifications, apostille, and consularization).
• Partnering with global regulatory affiliates and leveraging product expertise to provide submission documentation for expedited international market access and sustaining support.
• Assessing global impact of changes to launched products and supporting notifications/submissions as required.
• Providing import/export information to support shipments by researching existing documentation, preparing summary information, memos or statements as appropriate.
• Participating in the annual renewals of establishment registrations, device listings and licenses (domestic and international), by verifying changes made to existing products, licenses, clearance or approvals.

Maintain knowledge and application skills of regulations, standards and codes within job scope by:

• Acquiring and applying a broad knowledge and understanding of the regulatory and legal frameworks, processes, and procedures to maintain regulatory compliance of marketed products.
• Monitoring and evaluating medical device regulation changes and developing and executing strategies for maintaining products on the global market.

Performs other duties as needed and assigned.

Your Qualifications

Education: BS degree in a scientific discipline, preferably in the Life Sciences, Biomedical, Mechanical engineering or the equivalent in education, training and experience.

Related Experience: Minimum of 3-6 years of Regulatory experience in medical device industry is required. Minimum of 2 years of experience in working with regulatory agencies (i.e., FDA) and competent authorities.

Special Competencies or Certifications: Knowledge of U.S. and International regulatory requirements for medical devices. Proven record of supporting project teams. Excellent written and oral communication skills. Knowledge of current ISO 9001, ISO 13485, CMDR SOR/98-282, MDD 93/42/EEC, J GMP and 21 CFR Part 820.

Work Environment / Conditions: Ability to work together with others and in a team atmosphere; while displaying civility, cordiality, friendliness, empathy, etc. Ability to work in a fast paced environment with varying amounts of individual responsibilities, conflict resolution, redirected priorities, etc. Ability to travel nationally/internationally, up to 5-10% of the time.

The targeted pay range for this position is typically between $84,100 - $100,900. We note that the base pay offered is based on market location and may vary further depending on individualized factors for job candidates, such as job related knowledge, skills, experience, and other objective business considerations. This position is eligible for the following additional compensation: annual bonus.

Benefits

We offer a competitive benefits package that may include: Medical, dental, and vision insurance; Life, short- and long-term disability coverage; 401(k) with company match; Over 4 weeks of paid time off, plus holidays and parental leave; Flexible spending accounts and employee assistance program.

Equal Opportunity Employer Draeger is an Equal Opportunity Employer.

Application Please, apply directly through our career portal. We look forward to receiving your application.