Regulatory Affairs Fellow - Ad Promo

Location:

US-MA-Waltham

About the Role
Boston Scientific recognizes the importance of compliant marketing and is seeking a Regulatory Affairs Fellow to support the review and approval of advertising, promotional, sales support, and training materials for its Electrophysiology medical devices. The Fellow applies a risk‑based regulatory mindset to ensure that all materials are accurate, balanced, appropriately substantiated, and aligned with applicable regulations and internal procedures. This role partners cross‑functionally to enable compliant and effective communication that supports business objectives while protecting patients and the company.

Work Model and Sponsorship
The position follows a hybrid work model requiring presence in the local office at least three days per week. Boston Scientific does not offer sponsorship or visa support for this role.

Your Responsibilities Will Include

Review and provide regulatory feedback on advertising and promotional materials, including print, digital, web, email, social media, video, webinars, sales aids, and training or education materials.

Assess proposed product claims for alignment with cleared or approved indications.

Evaluate content for appropriate context, fair balance, and compliant presentation of benefits, risks, limitations, and required disclosures.

Recommend clear, actionable edits to strengthen compliance while supporting commercial objectives.

Confirm that promotional claims are supported by appropriate clinical, performance, or bench evidence and are referenced correctly.

Escalate high‑risk or novel claims, comparative statements, testimonials, and graphics or data visualizations for cross‑functional review.

Follow applicable SOPs and work instructions for promotional material review and approval; ensure review records are complete, appropriately documented, and stored.

Contribute to continuous improvement by identifying recurring issues, proposing mitigations, and supporting updates to templates and job aids.

Partner with Marketing and content creators early in the development process to guide compliant concepts and messaging.

Collaborate with Medical, Clinical, Legal, Quality, Compliance, and Product teams to resolve questions related to evidence, labeling alignment, and risk communications.

Participate in cross‑functional promotional review forums and meetings and clearly document and communicate decisions.

Assist with developing and delivering training materials, FAQs, and checklists for Marketing and other stakeholders as assigned.

Represent Regulatory when promotional and advertising materials are reviewed during FDA and Notified Body audits.

Required Qualifications

Bachelor’s degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.

Minimum of 10 years’ experience in Regulatory Affairs or related compliance within the medical device industry and experience directly reviewing advertising, promotional, sales, and training materials for medical devices.

Demonstrated working knowledge of FDA and EU regulatory frameworks impacting medical device promotion and communications.

Experience evaluating product claims for alignment with cleared or approved indications for use.

Experience assessing clinical, performance, and bench data to substantiate promotional claims.

Experience applying regulatory requirements related to fair balance, risk communication, and required disclosures within promotional materials.

Experience participating in cross‑functional promotional review processes or committees.

Proficiency with Microsoft Office applications, including Word, Excel, and PowerPoint.

Preferred Qualifications

Advanced degree in life sciences, engineering, pharmacy, public health, communications, or a related discipline.

Strong written and verbal communication skills with the ability to translate regulatory requirements into clear, actionable guidance for non‑regulatory audiences.

Demonstrated ability to influence without authority and collaborate effectively within cross‑functional teams.

Strong writing, editing, and critical‑thinking skills with attention to detail.

Organizational skills with an audit‑ready mindset and documentation discipline.

Learning agility and a continuous improvement orientation.

Pragmatic problem‑solving skills and a coaching mindset.

Salary Range
Minimum Salary:

$131,700

Maximum Salary:

$250,200

Compensation will vary based on location and the candidate’s experience and qualifications. Variation may include variable compensation such as overtime, shift differential, annual bonuses, or long‑term incentives, as appropriate.

Equal Employment Opportunity
Boston Scientific Corporation is an equal‑opportunity employer. All employment decisions are made without regard to race, religion, color, national origin, citizenship, sex, sexual orientation, gender identity, gender expression, veteran status, age, mental or physical disability, genetic information, or any other protected class.

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