Sr. Manager, Regulatory Affairs - Surgical/Medical Device

Posted on Nov 15, 2018 by Affinity Executive Search

New Jersey, NJ
Senior Appointments
Immediate Start
Annual Salary
The Surgical Regulatory Affairs Sr Manager handles all regulatory development aspects of surgical devices. The incumbent participates on the product development team to provide regulatory guidance for surgical devices assigned. They also manage relevant regulatory strategy components and interactions with Regulatory Authorities for their assigned surgical products and may perform due diligence efforts on new product opportunities.

Responsibilities may include but are not limited to:
Responsible for developing a global product regulatory strategy for surgical devices
Liaise with global regulatory counterparts to ensure regional requirements are incorporated into product strategy development
Develop a product regulatory timeline aligned to the companys product development, with key regulatory milestone, and activities for agency filing
Coordinate with the team on the development of product labels
Ensure labeling content and product documentation is developed in accordance with regulatory requirements
Participate as a member of the product development team(s) to build awareness of Regulatory Authority requirements and timing for submissions
Coordinate with key partners and regional counterparts to ensure timely and accurate submissions to Regulatory Authorities
Act as a regulatory contact for assigned country Regulatory Authorities for surgical devices
Liaise with country-specific surgical Regulatory Affairs personnel for international submissions and registrations
Manage interactions with other company functions (e.g., Quality, Compliance) during Regulatory Authority inspections
Provide regulatory guidance/input to surgical device change control and internal product review boards
Manage assigned personnel
Other job responsibilities as needed.

Supervise direct reports: Yes

Scope of Position: Support all North America Surgical sites.


Internal Customers/Business Partners:

* Quality Assurance
* Research and Development
* Manufacturing
* Global Product Surveillance and Safety
* Commercial Teams
* Medical and Clinical Affairs
* External Customers/Business Partners:
* Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)
* MDs/ODs

External Customers/Business Partners:

Audit/Inspection Organizations (FDA, Notified Bodies, International Regulatory Agencies)

Knowledge of surgical device regulatory affairs discipline throughout the product lifecycle, including Design, Development, Promotion and Advertising, Labeling, Change Control, Commercialization, and Operations
Knowledge of domestic and international laws, regulations, and guidance that affect assigned devices
Knowledge of clinical development, including responsibilities for successful management of development milestones, and/or marketing authorization, meeting facilitation, labeling negotiations, and regulatory responses
Ability to interpret Regulatory Authority policies and guidance and correctly apply them as appropriate in product development and labeling regulatory activities for assigned devices
Ability to influence and partner with cross-functional teams in a global surgical organization
Ability to take innovative ideas from proof of concept to promote a successful product regulatory strategy and increase probability of regulatory approval
Ability to critically review detailed scientific information and assess whether technical arguments are presented clearly and conclusions are adequately supported by data
Ability to assess project risks, and where appropriate, recommend contingency plans and strategies to mitigate regulatory risks

Demonstrated ability in analytical reasoning and critical thinking skills
Strong capability to contribute and lead a team environment
Strong business acumen and ability to see the business drivers outside of Regulatory Affairs
Excellent communication skills; both oral and written
Strong interpersonal skills with the ability to influence others in a positive and effective manner
Demonstrated ability to contribute to a continuous learning and process improvement environment
Capacity to react quickly and decisively in unexpected situations
Detail-oriented with the ability to proofread and check documents for accuracy and inconsistencies
Focused ability to influence operational excellence and performance metrics
Risk adverse where needed with the ability to identify potential solutions to complex problems


10+ years relevant medical device industry and regulatory experience
Ophthalmic Surgical device regulatory experience highly preferred
Bachelors degree in science or health related field
Advanced degree preferred (PhD, MD, MS, PharmD, or equivalent)

Reference: 559199043