Regulatory Affairs Specialist II

Anika Therapeutics, Inc.; Bedford (MA); Vor Ort; USD 90.000 - 120.000; Vollzeit

Zusammenfassung

Anika is seeking a Regulatory Affairs Specialist II to support regulatory submissions, authority interactions, and post-approval activities. The role requires preparing documentation, maintaining compliance, and guiding cross-functional teams through regulatory processes.

The position emphasizes attention to detail, strong organizational skills, and the ability to manage multiple priorities in a fast-paced environment, with hybrid work based in Bedford, MA.

Qualifikationen

• Bachelor’s degree in Life Sciences or related field, or equivalent experience.
• 2+ years of regulatory affairs experience.
• Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
• General understanding of global and U.S. regulatory processes.
• Excellent written and verbal communication and strong project management skills, with ability to manage multiple priorities.

Aufgaben

• Prepares regulatory documentation packages for review and submission to regulatory agencies and commercial partners to achieve departmental and organizational objectives.
• Prepares, submits, and archives 510(k)s, Letters to File, EU MDR technical documentation, and Change Notifications.
• Responds to FDA and Notified Body submission queries and supports regulatory authority interactions.
• Provides regulatory support for post-launch business maintenance activities under guidance of Senior Regulatory Affairs personnel.
• Reviews labeling and engineering changes for compliance with regulatory filings.
• Maintains current knowledge of FDA, ICH, and international regulatory guidelines and requirements.
• Collaborates with cross-functional teams and commercial partners to support regulatory submissions, product changes, and post-approval activities.
• Performs other duties and projects as assigned.

Kenntnisse

Regulatory affairs

510(k) submissions

EU MDR experience

Project management

Attention to detail

Cross-functional collaboration

Ausbildung

Bachelor’s degree in Life Sciences or related field

Jobbeschreibung

What You’ll Do

The Regulatory Affairs Specialist II supports regulatory submissions and regulatory authority interactions related to product submissions and approvals. In this role, you will prepare and submit regulatory documentation, support product market approval and post-approval activities, and provide regulatory guidance to cross-functional teams to ensure compliance with applicable requirements.

How You’ll Contribute

• Prepares regulatory documentation packages for review and submission to regulatory agencies and commercial partners to achieve departmental and organizational objectives.
• Prepares, submits, and archives 510(k)s, Letters to File, EU MDR technical documentation, and Change Notifications.
• Responds to FDA and Notified Body (NB) submission queries and supports regulatory authority interactions.
• Provides regulatory support for post-launch business maintenance activities under the guidance of Senior Regulatory Affairs personnel.
• Reviews labeling and engineering changes for compliance with regulatory filings.
• Maintains current knowledge of FDA, ICH, and international regulatory guidelines and requirements.
• Collaborates with cross-functional teams and commercial partners to support regulatory submissions, product changes, and post-approval activities.
• Performs other duties and projects as assigned.

What It Takes

This role is responsible for supporting regulatory submissions and product lifecycle activities that are essential to maintaining regulatory compliance and supporting product market approval. The position requires strong attention to detail, organizational skills, and the ability to manage multiple priorities in a fast-paced, changing environment. Success in this role requires sound regulatory judgment, effective communication, strong follow-through, and the ability to work independently while collaborating effectively with cross-functional teams and commercial partners.

What You Bring

• Bachelor’s degree, preferably in Life Sciences or a related field, or equivalent experience.
• 2+ years of regulatory affairs experience.
• Experience with 510(k)s and EU MDR applications, supplements, change notifications, and approvals.
• General understanding of global and U.S. regulatory processes.
• Strong organizational and follow-up skills, with excellent attention to detail.
• Excellent project management skills with the ability to manage multiple priorities and meet deadlines.
• Ability to work effectively within a team and independently as an individual contributor in a fast-paced, changing environment.
• Excellent written and verbal communication skills, including presentation skills and the ability to effectively present information using presentation platforms.

The salary range provided is based on the Company’s reasonable estimate of the base salary pay range for this position at the time of posting. Actual base pay is determined by several factors relevant to the position, including skills, competencies, experience, education, and geographic location. Anika also offers a discretionary bonus program for all full-time employees, comprehensive healthcare benefits, health savings account, 401(k) plan with up to 5% company match which includes immediate vesting, employee stock purchase plan at a 15% discount, accrued paid time off, additional long-term incentives including stock awards, and much more. At Anika, we take pride in offering robust Total Rewards, inclusive of market-leading benefits to meet our employees where they are in their career and in life.

The compensation and benefits information is provided as of the date of this posting. Anika reserves the right to modify compensation and benefits at any time, subject to applicable law.

Hybrid position based in Bedford, MA