Senior Biocompatibility Expert – Project-Based Contractor

Overview:

The Senior Biocompatibility Expert is an ad hoc, project-based independently contracted role serving as Groenakker's senior technical authority for the biological evaluation of medical devices. Work is

assigned per project rather than on a fixed weekly schedule. As part of Groenakker's global

Operations team, this role owns biological evaluation planning and reporting, defines and defends

test strategy across the ISO 10993 series, and provides direct technical support to medical device

manufacturers through regulatory review. The scope of this role is medical device biological safety

specifically, not general chemical, industrial, or consumer product safety assessment.

Engagement Model:

• Work is assigned ad hoc on a project-by-project basis. There is no fixed weekly hour

commitment, no minimum guaranteed volume of work, and no set schedule.

• The role is fully remote and open to candidates located anywhere in the world. The

contractor is responsible for their own tax status, business registration or entity of record,

and any employment, insurance, or licensing obligations applicable in their jurisdiction.

• Sufficient overlap with United States Eastern Time is required to support client calls and

internal review; a minimum of three overlapping working hours per business day is

expected.

• Professional written and spoken English fluency is required, as all deliverables and client

communications are produced in English.

Essential Duties and Responsibilities:

• Author, review, and defend Biological Evaluation Plans (BEP) and Biological Evaluation

Reports (BER) for medical devices in accordance with ISO 10993-1 and the FDA guidance

“Use of International Standard ISO 10993-1” (2023).

• Establish device categorization by nature and duration of body contact, determine the

biological endpoints requiring evaluation, and justify how each endpoint is addressed

through existing data, chemical characterization, or testing.

• Design biological test programs and specify extraction conditions, extraction ratios,

vehicles, and required sample quantities in accordance with ISO 10993-12, using surface-

area-based sample sizing for solid devices.

• Select, qualify, and technically oversee contract laboratories, including protocol review,

study monitoring, and audit of final reports for scientific and regulatory adequacy.

• Apply the relevant parts of the ISO 10993 series — including -5 cytotoxicity, -10

sensitization, -11 systemic toxicity, -17 allowable limits, -18 chemical characterization, and -

23 irritation — and ISO 18562 for breathing-gas pathway devices.

• Interpret extractables and leachables data sets and coordinate with toxicology to convert

chemical characterization results into a defensible device risk position.

• Author biocompatibility content for regulatory submissions and defend strategy in FDA Pre-

Submissions, 510(k) reviews, Additional Information requests, and European MDR

technical documentation.

• Perform gap analysis and impact assessment when standards, guidance, or FDA

recognition status change — for example the partial recognition of ISO 10993-1:2025 under

Recognition No. 2-313 — and advise on the effect to active client programs.

• Train and mentor junior specialists and reviewers, sharing best practices in biological

evaluation strategy, sample sizing, and documentation.

• Perform other project-related duties as agreed within the applicable Statement of Work.

Basic Qualifications:

• +8 Years hands-on experience in medical device biological evaluation, including direct

ownership of BEP and BER deliverables.

• A bachelor's degree or higher in a relevant scientific or engineering field.

• Demonstrated working command of the ISO 10993 series as applied to regulated medical

devices.

• Direct experience supporting medical device regulatory submissions to FDA and/or under

the European MDR.

Preferred Knowledge Skills and Abilities:

• An advanced degree (master's or doctorate) in a relevant scientific field.

• Board certification in toxicology (DABT, ERT, or equivalent).

• Experience defending biocompatibility strategy directly with FDA reviewers in a Pre-

Submission or Additional Information exchange.

• Familiarity with ISO 18562, USP <87> and <88>, and chemical characterization method

development.

• Experience with contract laboratory qualification and study monitoring.

• Excellent communication skills and customer-oriented empathy.

• Ability to effectively work remotely with limited supervision while managing concurrent client

projects.

Travel Requirements:

• Travel is not required as part of this role.

• Occasional optional travel to a client site, contract laboratory, or industry conference may

be proposed and separately agreed within a specific Statement of Work